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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

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(Last updated: May 08, 2024)

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AKT

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ROS1

TP53

NEAREST SITE: 2 miles
Zuckerberg San Francisco General Hospital
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05812807

Pembrolizumab Immunotherapy or Observation to Prevent Recurrence for Stage I-III Triple Negative Breast Cancer

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy With Checkpoint Inhibitor Therapy Scientific Title

Purpose

To determine if observation will result in the same risk of cancer coming back (recurrence) as pembrolizumab (Keytruda®) immunotherapy after neoadjuvant (before surgery) therapy and surgery.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have no residual disease after neoadjuvant (before surgery) chemotherapy and pembolizumab (Keytruda®) and negative margins after surgery. Full eligibility criteria

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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Observation (no treatment)</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Immunotherapy may help the body's immune system attack cancer and may reduce the ability of tumor cells to grow and spread.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li> <li class="seamTextUnorderedListItem">A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed.</li> <li class="seamTextUnorderedListItem">In this trial, ER and PR low are defined as 1-10% of cells that are ER or PR positive.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05812807' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03095352

Keytruda plus Carboplatin to Treat Chest Wall Breast Cancer

A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Scientific Title

Purpose

To compare the safety and effects (good and bad) of giving immunotherapy along with chemotherapy versus giving chemotherapy alone to treat breast cancer that has spread to the chest wall.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has spread to the chest wall and cannot be removed by surgery. Full eligibility criteria

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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment </li> </ul> Group 2: Standard treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Biopsies and blood samples before and after treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is the immunotherapy drug used in this study. It is a PD-1 inhibitor approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is the chemotherapy used in this study.</li> <li class="seamTextUnorderedListItem">In this trial, researchers will test tumor biopsies and blood samples before and after treatment in order to learn more about how genes and the immune system affect how tumors respond to immunotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03095352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.TPS1113' target='_blank'>ASCO Abstract: Pembrolizumab and Carboplatin</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05239143

P-MUC1C-ALLO1 CAR-T Cell Immunotherapy for Advanced Breast Cancer

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of P-MUC1C-ALLO1, an experimental CAR-T cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, 1 session</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 CAR-T cell immunotherapy, by IV, multiple sessions</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) may be given for safety</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">P-MUC1C-ALLO1 is an experimental immunotherapy called CAR-T cell therapy.</li> <li class="seamTextUnorderedListItem">Allogeneic CAR-T cell therapy is an immunotherapy made from donor immune cells.</li> <li class="seamTextUnorderedListItem">Donor immune cells are modified with chimeric antigen receptors (CARs) so they can attack cancer cells.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">Rimiducid (CaspaCIDe®) is an enzyme that can be administered for safety to kill CAR-T cells, if needed.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05239143' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://poseida.com/science/pipeline/#cart-therapies' target='_blank'>Poseida Therapeutics Drug Information Page: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/poseida-therapeutics-announces-fda-clearance-of-investigational-new-drug-application-for-p-muc1c-allo1-a-fully-allogeneic-car-t-targeting-multiple-solid-tumors-301447910.html' target='_blank'>Poseida Therapeutics Press Release: P-MUC1C-ALLO1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bellicum.com/caspacide-safety-switch/' target='_blank'>Bellicum Phamaceuticals Drug Information Page: Rimiducid (CaspaCIDe®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2020.618427/full' target='_blank'>Journal Article: Allogeneic CAR T-Cell Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 3 miles
GSK Investigational Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05277051

GSK4381562 Immunotherapy for Advanced Breast Cancer

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of GSK4381562 (SRF813), an experimental immunotherapy, alone and with dostarlimab (Jemperli®), a type of immunotherapy called a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813)</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GSK4381562 (SRF813) is an experimental immunotherapy that targets PVRIG/SRF813 to activate immune cells to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05277051' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.surfaceoncology.com/news-releases/news-release-details/surface-oncology-achieves-30-million-milestone-first-patient' target='_blank'>Surface Oncology Press Release: First Patient Dosed with GSK4381562 (SRF813)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/jemperli' target='_blank'>Breastcancer.org: Dostarlimab (Jemperli®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center
San Francisco,CA

VISITS: 1-2 visits every 3 weeks for 6 months

PHASE: III

NCT ID: NCT05633654

Sacituzumab Govitecan with Pembrolizumab for Stage I-III Triple Negative Breast Cancer with Residual Disease

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan (Trodelvy®) antibody drug conjugate with pembrolizumab (Keytruda®) immunotherapy, a PD-1 inhibitor.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer with residual disease after neoadjuvant (before surgery) treatment and surgery. You must not have a BRCA mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off, 6 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months (optional)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan(Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05633654' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Comprehensive Cancer Ctr
San Francisco,CA

VISITS: 1 visit every 1-2 weeks

PHASE: II

NCT ID: NCT05852691

RO7247669 Bispecific Antibody with Chemotherapy for Advanced Triple Negative or HER2 Low, PD-L1 Positive Breast Cancer

A Phase II, Multicenter, Randomized, Double-Blind Study of RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of RO7247669, an experimental targeted therapy, with nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is PD-L1 positive. You must have not yet received treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7247669 is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">RO7247669 is a bispecific antibody that targets PD-1 (programmed death-1) and LAG-3 (lymphocyte-activation gene 3).</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05852691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tobemstomig' target='_blank'>National Cancer Institute: Tobemstomig (RO7247669)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-Paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: 1 visit every week for 3-6 months

PHASE: II

NCT ID: NCT01042379

I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.

Who is this for?

People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following before surgery: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03971409

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or ER Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe) Scientific Title

Purpose

To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or ER Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/binimetinib' target='_blank'>NCI Drug Dictionary: Binimetinib</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04143711

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Metastatic Breast Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of DF1001 when it is given alone or with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests HER2 1+, 2+ or 3+ on the IHC (immunohistochemistry) tumor test and have not had more than three lines of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 immunotherapy</li> </ul> You may also receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04143711' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/msi-h/' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dragonflytx.com/copy-of-about-us-1' target='_blank'>Dragonfly Therapeutics Information Page: DF1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554437/' target='_blank'>Journal Article: Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/keytruda-approved-for-microsatellite-instability-high-and-mismatch-repair-deficient-cancers' target='_blank'>Cure Today: Keytruda Approved for Any Solid Tumor With a Specific Genetic Marker</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05929768

Shorter Chemotherapy and Immunotherapy Treatment Before Surgery for Stage I-III Triple Negative Breast Cancer

Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of shorter chemotherapy and immunotherapy treatment without doxorubicin (Adriamycin®) chemotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Usual Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Carboplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, before and/or after surgery</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Shorter chemotherapy treatment without doxorubicin (Adriamycin®) chemotherapy may work the same as usual chemotherapy treatment for stage I-III triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05929768' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Centre
San Francisco,CA

VISITS: 21 visits over 2 years

PHASE: III

NCT ID: NCT03562637

An Immunotherapy Combination for Stage I-III Triple Negative Breast or ER Low, HER2- Cancer That is Globo H Positive

A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI 822)/OBI 821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, Defined as Residual Invasive Disease Following Neoadjuvant Chemotherapy OR ≥4 Positive Axillary Nodes Scientific Title

Purpose

To study the safety and anti-cancer activity of giving a combination of two experimental immunotherapies after the standard of care has been completed.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have completed chemotherapy. You must have had cancer cells remaining if you had neoadjuvant (before surgery) chemotherapy or had 4 or more positive lymph nodes at the time of surgery if you had adjuvant (after surgery) chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) combined with OBI-821, by injection, 21 times over 2 years </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by injection, 21 times over 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagloxad simolenin (OBI-822) is the investigational immunotherapy used in this study. </li> <li class="seamTextUnorderedListItem">It is given along with the investigational drug OBI-821, which is designed to help stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03562637' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT03562637' target='_blank'>UCSF Trial Information Page: GLORIA</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/adagloxad-simolenin/' target='_blank'>Immuno-Oncology News: Adagloxad Simolenin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/saponin-based-immunoadjuvant-obi-821' target='_blank'>NCI Drug Dictionary: OBI-821</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/80/4_Supplement/OT1-08-03' target='_blank'>AACR Abstract: (OBI-822) and OBI-821</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05086692

MDNA11 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors (ABILITY) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of MDNA11, an experimental immunotherapy, alone and with a checkpoint inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Checkpoint inhibitor as determined by your physician</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MDNA11 is an experimental immunotherapy called interleukin-2 (IL-2).</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">A checkpoint inhibitor is a type of immunotherapy. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05086692' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medicenna.com/pipeline/mdna11/' target='_blank'>Medicenna Drug Information Page: MDNA11</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2021/12/22/2356750/0/en/Medicenna-Announces-Preliminary-Clinical-Data-Showing-Preferential-Stimulation-of-Anti-Cancer-Immune-Cells-with-MDNA11-Treatment-in-the-Phase-1-2-ABILITY-Study.html' target='_blank'>Medicenna Press Release: MDNA11 Treatment in the Phase 1/2 ABILITY Study</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cytokines' target='_blank'>Breastcancer.org: Interleukin-2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-checkpoint-inhibitors' target='_blank'>Breastcancer.org: Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/checkpoint-inhibitors' target='_blank'>Cancer Research UK: Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: 1 visit every 1-2 weeks for 5 months

PHASE: III

NCT ID: NCT06058377

Chemotherapy with Durvalumab Immunotherapy Before Surgery for Women with Stage II-III HR+, HER2- Breast Cancer

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care neoadjuvant (before surgery) chemotherapy with and without durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?

Women with newly diagnosed stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment. You must have a MammaPrint score of -1.0 to -0.57. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram</li> <li class="seamTextUnorderedListItem">MammaPrint testing (if not yet received)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2 weeks 2 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 2 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li> <li class="seamTextUnorderedListItem">MammaPrint® is a genetic test that use tumor samples to help guide treatment decisions and determine risk of recurrence (cancer coming back).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html#:~:text=Durvalumab%20injection%20is%20in%20a,the%20growth%20of%20cancer%20cells.' target='_blank'>Medline Plus: Durvalumab (Imfinzi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint Test</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03589339

Radiation-Activated NBTXR3 Nanoparticle and Immunotherapy for Metastatic Breast Cancer

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of NBTXR3, an experimental nanoparticle, and stereotaxic ablative radiotherapy, with nivolumab (Opdivo®) or pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the soft tissues, lungs, or liver. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3, by intratumoral injection, 1 time</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) or pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBTXR3 is an experimental nanoparticle designed to kill cancer cells that is activated by stereotaxic ablative radiotherapy.</li> <li class="seamTextUnorderedListItem">NBTXR3 will be injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">Stereotaxic ablative radiotherapy, also called stereotactic radiation or stereotactic radiosurgery, delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03589339' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nanobiotix.com/clinical-trials/' target='_blank'>Nanobiotix Drug Information Page: NBTXR3</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotaxic Ablative Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable, over 4 months

PHASE: NA

NCT ID: NCT02872025

Pembrolizumab Before Surgery for Women With High-Risk DCIS

Testing the Ability of Pembrolizumab to Alter the Tumor Immune MicroEnvironment (TIME) of High Risk DCIS Scientific Title

Purpose

To study the effects (good and bad) of the immunotherapy pembroluzuimab on DCIS and the tissue surrounding DCIS.

Who is this for?

Women with high-risk DCIS planning to have surgery (mastectomy or lumpectomy). Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by injection directly into the DCIS, 4 times, with 2 to 4 weeks between each injection</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), 1 to 5 weeks after your last injection</li> </ul> Group 2: Standard care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Tissue collection (biopsy of DCIS)</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), within 4 months of diagnosis</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">It is usually given by IV, but for this study it will be injected directly into the DCIS. </li> <li class="seamTextUnorderedListItem">Giving pembrolizumab (Keytruda®) before surgery allows researchers to study the effects it has on DCIS and the microenvironment (the tissue surrounding the DCIS).</li> <li class="seamTextUnorderedListItem">For this trial, high-risk DCIS means you meet at least 2 of the following: you are younger than 45, the DCIS is palpable (able to be felt by touch), larger than 5 cm, grade II-III, HER2 positive (HER2+), or hormone receptor negative (ER- and PR-).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02872025' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/dcis/diagnosis' target='_blank'>Breastcancer.org: Diagnosis of DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforDuctalCarcinomaInSitu.html' target='_blank'>Susan G. Komen: Treatment for DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT02872025' target='_blank'>University of California San Francisco: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/researchers/laura-j-esserman' target='_blank'>BCRF: Laura J. Esserman (Study Researcher)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=Cj0KCQjw6sHzBRCbARIsAF8FMpU1aXb3OCAoZH-Kz-lr_9qfn5S-yKDUnZ6zjvh8GAJBRQ5kuy7Ih0caAlUVE' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtecan ADC and Pembrolizumab Immunotherapy for Advanced HER2 Positive and HER2 Low Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda)</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University
Stanford,CA

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT04282044

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving an experimental immunotherapy made from cells from your own immune system.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make the immunotherapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CRX100, by IV</li> </ul> A hospital stay may be required
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CRX100 is the name of the immunotherapy used in this trial. It may work by directly killing cancer cells and by getting the immune system to go after and kill cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04282044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bioeclipse.com/clinical-trials-overview/' target='_blank'>BioEclipse Therapeutics Drug Information Page: CRX1000</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/25381063/' target='_blank'>Journal Article Abstract: Cytokine-Induced Killer (CIK) Cells in Cancer Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Health Care
Stanford,CA

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT05259696

E-602 Immunotherapy for Advanced Breast Cancer

A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Cancers (GLIMMER-01) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of E-602, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602, by IV, weekly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">E-602 is an experimental type of immunotherapy that allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05259696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://palleonpharma.com/pipeline/' target='_blank'>Palleon Pharmaceuticals Drug Information Page: E-602</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Institute
Palo Alto,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05082610

HMBD-002 Immunotherapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study of HMBD-002-V4C26 (HMBD-002), a Monoclonal Antibody Targeting VISTA, as Monotherapy and Combined With Pembrolizumab, in Patients With Advanced Solid Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of HMBD-002, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) PD-L1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HMBD-002 is an experimental immunotherapy that targets a protein called VISTA and may increase the immune system's ability to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05082610' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://hummingbirdbioscience.com/hmbd-002/' target='_blank'>Hummingbird Bioscience: HMBD-002 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.precisiononcologynews.com/cancer/hummingbird-bioscience-merck-study-hmbd-002-keytruda-various-solid-tumors' target='_blank'>Precision Oncology News: HMBD-002</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Palo Alto,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04278144

BDC-1001 With or Without Keytruda for People With Advanced HER2 Positive Breast Cancer

Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and HER2-Expressing Solid Tumors Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of giving the new immunotherapy drug BDC-1001 alone and with the PD-1 inhibitor pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no other treatment options available. Full eligibility criteria

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This is a 2-part study. Depending upon which part of the trial is open when you enroll, you will receive the following: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> </ul> Part 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-1001 is an investigational drug called an Immune Stimulating Antibody Conjugate. It combines an anti-HER2 drug with a drug that targets the TLR7/8 proteins. </li> <li class="seamTextUnorderedListItem">Researchers think targeting the TLR7/8 proteins can help make tumors more likely to respond to pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Pembrolizumab is another type of immunotherapy called a PD-1 inhibitor. It works by getting the immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04278144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://boltbio.com/#ourscience' target='_blank'>Drug Company Information Page: BDC-1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytru' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nationalbreastcancer.org/breast-cancer-targeted-therapy' target='_blank'>National Breast Cancer Foundation: Targeted Therapy (Monoclonal Antibodies)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Immune_stimulating_antibody_conjugate' target='_blank'>Wikipedia: Immune Stimulating Antibody Conjugate</a> </li></ul>

NEAREST SITE: 53 miles
St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare
Santa Rosa,CA

VISITS: 1 visit every 2-3 weeks

PHASE: III

NCT ID: NCT05382286

Sacituzumab Govitecan-hziy ADC and Pembrolizumab for Advanced PD-L1 Positive, Triple Negative Breast Cancer

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan-hziy (Trodelvy®), a type of targeted therapy called an antibody drug conjugate (ADC), with pembrolizumab (Keytruda®), a type of immunotherapy called a PD-1 inhibitor, compared to chemotherapy with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) PD-L1 positive (PD-L1+), triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: ADC with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Group 2: Chemotherapy with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> </ul> or <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) with carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> with: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), gemcitabine (Gemzar®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05382286' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy#:~:text=Trodelvy%20(chemical%20name%3A%20sacituzumab%20govitecan,two%20or%20more%20systemic%20therapies.' target='_blank'>Breastcancer.org: Sacituzumab govitecan-hziy (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation: Home</a> </li></ul>

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: Number of visits varies, ongoing

PHASE: II

NCT ID: NCT03606967

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of giving chemotherapy, the immunotherapy tremelimumab, and the PD-L1 inhibitor Durvalumab (Imfinzi®) together with or without a personalized synthetic long peptide (SLP) vaccine and Hiltonol® (poly-ICLC) .

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 negative and who have not yet received any treatment for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> Group 2: No Vaccine <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05673200

ASTX727 DNMT Inhibitor with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

Phase I Study Targeting DNA Methyltransferases in Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ASTX727, an experimental DNA methyltransferase (DNMT) inhibitor, with paclitaxel (Taxol®) chemotherapy and pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cedazuridine/Decitabine (ASTX727), by mouth</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">Biopsies, 2 times</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cedazuridine/Decitabine (ASTX727) is an experimental targeted therapy called a DNA methyltransferase (DNMT) inhibitor. It is a combination of two drugs, decitabine and cedazuridine.</li> <li class="seamTextUnorderedListItem">Cedazuridine prevents decitabine from degrading in the body so that decitabine will work better.</li> <li class="seamTextUnorderedListItem">Decitabine helps bone marrow produce normal blood cells and kill abnormal cells in the bone marrow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug that stops tumor cells from growing and dividing and may kill them.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 helps the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673200' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/oral-decitabine-and-cedazuridine-astx727-hematological-malignancies/' target='_blank'>Astex Pharmaceuticals: ASTX727 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 158 miles
California Cancer Associate for Research & Excellence
Fresno,CA

VISITS: 1 visit every 3 weeks, for 10 months

PHASE: III

NCT ID: NCT04873362

Additional Treatment for People with Stage I-III HER2+ Breast Cancer Who had Tumor Remaining after Receiving Treatment Before Surgery

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy Scientific Title

Purpose

To study and compare the anti-cancer activity, side effects, and safety of giving trastuzumab emtansine (Kadcyla®) alone or with atezolizumab (Tecentriq®) after neoadjuvant therapy and surgery.

Who is this for?

People with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who received chemotherapy and an anti-HER2 targeted therapy before surgery (neoadjuvant treatment). During surgery, your doctors must have found remaining tumor or cancer cells in your breast or lymph nodes (residual disease). Additionally, you must not have already received trastuzumab emtansine, atezolizumab, or any other checkpoint inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Placebo for atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months. </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 10 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, for 10 months.</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">Residual disease is when, during surgery, doctors find some remaining tumor in the breast or lymph nodes of a person who received neoadjuvant therapy. </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody — the HER2-targeted therapy trastuzumab — to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor or a checkpoint inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04873362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab (Tecentriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2020/residual-cancer-burden-is-prognostic-of-outcomes-across-breast-cancer-subtypes/' target='_blank'>The ASCO Post: Residual Cancer Burden Is Prognostic of Outcomes Across Breast Cancer Subtypes</a> </li></ul>

NEAREST SITE: 164 miles
Community Cancer Institute
Clovis,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04895709

BMS-986340 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BMS-986340, an experimental CCR8 inhibitor, alone or with nivolumab (Opdivo®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. You must have received at least 1 PD-1 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986340 is an experimental immunotherapy called a CCR8 inhibitor. BMS-986340 blocks the activity of CCR8 on immune cells to activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04895709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bolderscience.com/trial/NCT04895709/' target='_blank'>Bristol-Myers Squibb: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsscience.com/?s=BMS-986340+%26plusmn%3B+Nivolumab&search_cat=bms' target='_blank'>Bristol-Myers Squibb: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/assets/bms/us/en-us/pdf/CCR8-Immune-Pathway-Fact-Sheet.pdf' target='_blank'>Bristol-Myers Squibb: CCR8 Immune Pathway</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-ccr8-monoclonal-antibody-bms-986340?redirect=true' target='_blank'>National Cancer Institute: BMS-986340 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://chemocare.com/chemotherapy/drug-info/opdivo.aspx' target='_blank'>Chemocare: Nivolumab (Opdivo®)</a> </li></ul>

NEAREST SITE: 186 miles
Research Site
Reno,NV

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05629585

Dato-DXd Antibody Drug Conjugate for Stage I-III Triple-Negative Breast Cancer

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of Dato-DXd with or without durvalumab (Imfinzi®) compared with investigator's choice of therapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer with cancer that still remains in the breast and/or lymph nodes after neoadjuvant (before surgery; containing an anthracycline and/or a taxane) and surgery. You must not have received systemic therapy after surgery. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd), by IV, every 3 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd), by IV, every 3 weeks for 6 months</li> </ul> Group 3 (Investigator's Choice) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (for 2 weeks in a 3-week cycle) for 6 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (abbreviated Dato-DXd) is an antibody-drug conjugate that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor. It works by stimulating the body's immune system to go after cancer cells. It is approved to treat some cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05629585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Dato-DXd</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/asco-2021/asco-2021-breast-cancer-in-depth/breast-cancer-durvalumab-neoadjuvant-chemo-treatment-risk/#:~:text=June%2024%2C%202021-,Durvalumab%20Improves%20Survival%20When%20Added%20to,in%2' target='_blank'>Cancer Therapy Advisor: Durvalumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li></ul>

NEAREST SITE: 336 miles
UCLA Hematology/Oncology
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05585034

XmAb808 Bispecific Antibody with Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination With Pembrolizumab in Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of XmAb808, an experimental bispecific antibody, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb808</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb808 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">XmAb808 is a bispecific antibody that targets B7-H3 and CD28.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05585034' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://xencor.com/pipeline/' target='_blank'>Xencor Drug Information Page: XmAb808</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 339 miles
NGM Clinical Study Site
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05215574

NGM831 with Pembrolizumab for Advanced Breast Cancer

A Phase 1/1b Dose Escalation/Expansion Study of NGM831 as Monotherapy and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of NGM831, an experimental immunotherapy, alone and with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NGM831 is an experimental immunotherapy called an ILT3 inhibitor.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking ILT3 and PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05215574' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.ngmbio.com/news-releases/news-release-details/ngm-bio-discloses-fourth-oncology-development-candidate-ngm831' target='_blank'>NGM Bio Press Release: NGM831</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 339 miles
University of California, Los Angeles
Santa Monica,CA

VISITS: Hospital stay may be required

PHASE: I

NCT ID: NCT05274451

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental type of immunotherapy called CAR T-cell therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR1 positive breast cancer that has progressed on standard treatment. You must not have received T-cell therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 CAR T-cell therapy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 1 biopsy</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 is an experimental type of immunotherapy called CAR T-cell/CAR-T therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack ROR1 positive cancer cells</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1 positive cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05274451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lyell.com/our-pipeline' target='_blank'>Lyell Immunopharma Drug Information Page: LYL797</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Hematology/Oncology
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05887492

TNG260 Targeted Therapy with Immunotherapy for Advanced Breast Cancer with STK11 Mutations

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of TNG260, an experimental targeted therapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with STK11 mutations. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260 is an experimental targeted therapy called a CoREST inhibitor. CoREST inhibitors may activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: STK11</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05887492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/pipeline/' target='_blank'>Tango Therapeutics: TNG260 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/programs/corest/' target='_blank'>Tango Therapeutics: CoREST Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05888831

BMS-986449 With or Without Nivolumab for Advanced Breast Cancer

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BMS-986449, an experimental cancer drug, with and without nivolumab (Opdivo®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986449 is an experimental cancer drug.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05888831' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bmsstudyconnect.com/no/en/clinical-trials/NCT05888831.html' target='_blank'>Bristol-Myers Squib: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a614056.html' target='_blank'>MedLine Plus: Nivolumab (Opdivo®)</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Department of Medicine Hematology Oncology
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05180474

GEN1047 for Stage III or Stage IV Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of GEN1047, an experimental immunotherapy.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have progressed after or during at least one prior therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GEN1047 is a bispecific antibody that helps T cells kill cancer cells.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05180474' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/pipeline/' target='_blank'>Genmab: GEN1047</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Health (Santa Monica Cancer Care)
Santa Monica,CA

VISITS: 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT05708950

KVA12123 Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of KVA12123, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) immune checkpoint inhibitor.

Who is this for?

Postmenopausal women and men with advanced (some stage III) or advanced (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 1.5 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, every 1.5 months</li> <li class="seamTextUnorderedListItem">Physical exams</li> <li class="seamTextUnorderedListItem">Heart function tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KVA12123 is an experimental immunotherapy that binds to VISTA to stimulate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05708950' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://kinetabio.com/kva12123/' target='_blank'>Kineta: KVA12123 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05318469

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in PD-L1 Negative TNBC Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ivermectin (Stromectol®), an experimental anti-cancer drug, with balstilimab, an experimental immunotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have received 1-2 lines of chemotherapy or antibody-drug conjugate (ADC) for metastatic disease. You must not have received treatment with pembrolizumab (Keytruda®) or dostarlimab (Jemperli®) for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ivermectin (Stromectol®), by mouth, 3 days every week</li> <li class="seamTextUnorderedListItem">Balstilimab, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ivermectin (Stromectol®) is an anti-parasite medicine that may also help block the formation of growths that may become cancer. In this trial, ivermectin (Stromectol®) is considered experimental.</li> <li class="seamTextUnorderedListItem">Bastilimab is an experimental immunotherapy called a CTLA-4 inhibitor, which is a type of immune checkpoint inhibitor. Blocking CTLA-4 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Giving ivermectin with balstilimab may increase the ability of balstilimab to shrink tumors in people with triple negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05318469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/breakthroughs/drug-combo-shows-promise-against-triple-negative-breast-cancer' target='_blank'>City of Hope: The Effect of Ivermectin and Bastilimab Together on Enhancing the Immune System's Ability to Kill Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20954-ivermectin-tablets' target='_blank'>Cleveland Clinic: Ivermectin (Stromectol®)</a> </li></ul>

NEAREST SITE: 341 miles
Cedars Sinai Medical Center
Los Angeles,CA

VISITS: Number of visits unavailable, over 2 months

PHASE: II

NCT ID: NCT03546686

Immunotherapy & Cryoablation Before Surgery in Taxane Treated Triple Negative or ER Low, HER2- Tumors

A Randomized Phase 2 Study of Peri-Operative Ipilimumab, Nivolumab and Cryoablation Versus Standard Peri-Operative Care in Women With Hormone Receptor-Negative, HER2-Negative Early Stage/Resectable Breast Cancer. Scientific Title

Purpose

To study the safety and effects (good and bad) of using cryoablation, ipilimumab (Yervoy®) and nivolumab (Opdivo ®) after neoadjuvant chemotherapy and before surgery.

Who is this for?

Women with stage I, stage II, or stage IIIa triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who had taxane-based chemotherapy before surgery and still have some tumor remaining. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, 1-5 days prior to core biopsy and cryoablation</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, 1-5 days prior to core biopsy and cryoablation, and then every 2 weeks after surgery, for 6 weeks</li> <li class="seamTextUnorderedListItem">Core biopsy/Cryoablation, 7-10 days prior to surgery</li> <li class="seamTextUnorderedListItem">Breast surgery (standard-of-care) </li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cryoablation uses extreme cold to kill cancer cells. It is not an established breast cancer treatment. </li> <li class="seamTextUnorderedListItem">Yervoy is an immunotherapy. It gets the immune system to see cancer cells by blocking the CTLA-4 protein. It is approved to treat metastatic melanoma. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Opdivo is an immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03546686' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/ipilimumab-yervoy' target='_blank'>Cancer Research UK: Ipilimumab (Yervoy)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Nivolumab.aspx' target='_blank'>Chemocare: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/surgery/cryotherapy' target='_blank'>Breastcancer.org: Cryotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2018/11/181128082721.htm' target='_blank'>Science Daily: Cryoablation</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 10 visits within 2 months

PHASE: II

NCT ID: NCT05491226

Immunotherapy, Targeted Therapy, and Radiation Therapy for Women with Stage I-III Triple Negative Breast Cancer

IIT2021-01-Shiao-CSF1Ri: Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, axatilimab, an experimental targeted therapy, and radiation therapy.

Who is this for?

Women with stage I, stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is high risk for recurrence (coming back) and who have not yet received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 1.5 months</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily for 3 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab, by IV, weekly for 1 month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Axatilimab is an experimental targeted therapy called a CSF-1R inhibitor. Blocking CSR-1R may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ and ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05491226' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndax.com/pipeline/axatilimab/' target='_blank'>Syndax: Axatilimab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 341 miles
Cedars Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05941507

LCB84 Antibody Drug Conjugate With and Without Immunotherapy for Advanced Breast Cancer

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LCB84, an experimental antibody drug conjugate (ADC), with or without a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">PD-1 inhibitor, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LCB84 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">LCB84's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called MMAE.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called immune checkpoint inhibitors. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05941507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/checkpoint-inhibitors' target='_blank'>National Cancer Institute: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03025035

Keytruda for Advanced BRCA+ Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Advanced BRCA-mutated Breast Cancers Scientific Title

Purpose

To look at the safety and effects (good and bad) of using the immunotherapy drug pembrolizumab (Keytruda®) to treat advanced or metastatic breast cancer in patients with a BRCA mutation.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer and have been tested and told that you have an inherited BRCA (BRCA1 or BRCA2) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancers, including breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03025035' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet' target='_blank'>NCI: BRCA1 and BRCA2</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li></ul>

NEAREST SITE: 348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 7 visits every 3 weeks for 3 months

PHASE: I

NCT ID: NCT04616248

Immunotherapy and Radiation Therapy for Metastatic HER2 Negative Breast Cancer

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301, CDX-1140, and Poly ICLC (Hiltonol®) immunotherapies with radiation therapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every 3 weeks for 3 months</li> </ul> followed 3-4 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 1 day every 3 weeks for 3 months</li> </ul> followed 1 day later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-1140, by infusion and/or injection, 1 day every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®), by injection, 1 day every 3 weeks for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 is an experimental immunotherapy called a Flt3 agonist, which means it binds to Flt3 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-1140 is an experimental immunotherapy called a CD40 agonist, which means it binds to CD40 on immune cells to target and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®) is an immunotherapy that stimulates immune cells to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04616248' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-flt3-ligand' target='_blank'>National Cancer Institute: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC (Hiltonol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com/science' target='_blank'>Oncovir: Poly ICLC (Hiltonol®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 348 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04585750

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PC14586, an experimental p53 reactivator, alone or with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a TP53 Y220C mutation who have received at least 1 line of therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586 is an experimental targeted therapy called a p53 reactivator which may stop the mutated p53 protein from working and cause cancer cell death.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53 Y220C</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04585750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pmvpharma.com/pipeline/' target='_blank'>PMV Pharmaceuticals: PC14586 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 348 miles
Los Angeles General Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04333706

Sarilumab Immunotherapy with Chemotherapy After Surgery for Stage I-III Triple Negative Breast Cancer

A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of sarilumab (Kevzara®) immunotherapy with capecitabine (Xeloda®) chemotherapy.

Who is this for?

People with stage I, stage II or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer with residual disease (cancer that remains after surgery). Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®), by injection, every 3 weeks, up to 3 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, up to 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, up to 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®) is approved to treat people with certain types of arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Sarilumab (Kevzara®) targets a molecule made by the immune system and may have anti-cancer effects.</li> <li class="seamTextUnorderedListItem">Residual disease is cancer that remains after surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04333706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617032.html' target='_blank'>Medline Plus: Sarilumab Drug Information Page</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: Every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02778685

Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer

Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of adding the immunotherapy drug pembrolizumab (Keytruda®) to the commonly used combination of the anti-estrogen drug letrozole (Femara®) and the CDK 4/6 inhibitor palbociclib (Ibrance®).

Who is this for?

Women with metastatic (stage IV) estrogen receptor positive (ER+) HER2 negative (HER2-) breast cancer who have not yet started treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and palbociclib (Ibrance®) are an already approved therapy combination. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is an anti-estrogen therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwycfkBRAFEiwAnLX5IZ2WUInCzwQ56GHMYYq-KXijoX1dzOK1O8HBbmaxajT0CPi2CbX3sRoC3A4QA' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/the-evolving-field-of-erpositive-metastatic-breast-cancer-care' target='_blank'>Cure Today: The Evolving Field of ER Positive-Metastatic BC</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03424005

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) Scientific Title

Purpose

To study the safety and effects (good and bad) of 7 different immunotherapy-based treatment combinations in people with triple negative (ER-/PR-/HER2-) breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy. Full eligibility criteria

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You will be randomly assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (2 weeks on, 1 week off), ongoing </li> </ul> Group 7 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Physician's choice chemotherapy (gemcitabine/Gemzar® plus carboplatin/Paraplatin®, or eribulin/Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq is approved to treat certain types of urinary, bladder and lung cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®).</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03424005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT04020575

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for MUC 1*

Adoptive Immunotherapy for Advanced MUC1* Positive Breast Cancer With Autologous T Cells Engineered to Express a Chimeric Antigen Receptor, huMNC2-CAR44 Specific for a Cleaved Form of MUC1 (MUC1*) Scientific Title

Purpose

To look at the safety, best dose and effects of an experimental CAR T-cell immunotherapy that targets cancer cells that test positive for MUC1*, a special type of the MUC1 protein.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for MUC1 and who have already received at least one standard therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your personalized CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Chemotherapy to deplete your lymph cells</li> <li class="seamTextUnorderedListItem">huMNC2-CAR44 CAR T-cells, by IV</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T cell or CAR-T cell therapy is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack MUC1 on cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04020575' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/car-t-cell-therapy.html' target='_blank'>MD Anderson Cancer Center: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/research/car-t-cells' target='_blank'>NCI: Car T-Cells</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.minervabio.com/clinical-trial-humnc2-car44-in-mbc/' target='_blank'>Minerva Biotechnologies: Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT03696030

CAR T-Cell Immunotherapy in HER2+ Breast Cancer with Brain or Leptomeningeal Metastases

A Phase 1 Cellular Immunotherapy Study of Intraventricularly Administered Autologous HER2-Targeted Chimeric Antigen Receptor (HER2-CAR) T Cells in Patients With Brain and/or Leptomeningeal Metastases From HER2 Positive Cancers Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of a CAR T-cell immunotherapy that is delivered directly into the brain.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with brain or leptomeningeal metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make your HER2 CAR T-cell therapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">Surgery to place a device (similar to a chemotherapy port) under your scalp</li> <li class="seamTextUnorderedListItem">HER2 CAR T-cells, by injection, weekly, 3 times</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required. Follow up <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Every 2 months for 1 year, then every year for 15 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack HER2+ cancer cells.</li> <li class="seamTextUnorderedListItem">You will have surgery to insert a device under your scalp so that the CAR T-cell therapy can be infused directly into your brain.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03696030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cityofhope.org/physician-news/breast-cancer-car-t-cell-therapy' target='_blank'>City of Hope Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-cell Therapy and Its Side Effects</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Metastases</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer Center
Duarte,CA

VISITS: At least every 3 weeks

PHASE: I-II

NCT ID: NCT05070247

TAK-500 ADC with Pembrolizumab for Advanced Triple Negative Breast Cancer

An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of TAK-500, an experimental type of targeted therapy called an antibody drug conjugate (ADC), with pembrolizumab (Keytruda®), a type of immunotherapy called a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has progressed on standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-500, by IV, every 2 or 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAK-500 is an experimental type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Its antibody targets and activates STING, a pathway that activates the immune system to attack cancer cells, and it delivers an anti-cancer drug called TAK-676.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05070247' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.takeda.com/49c795/siteassets/system/investors/investor--events/asco-2021-ir-event_en.pdf' target='_blank'>Takeda Drug Information Presentation (Slide 23): TAK-500</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 359 miles
The Oncology Institute
Whittier,CA

VISITS: Number of visits unavailable

PHASE: II-III

NCT ID: NCT05747794

Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy

AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of eftilagimod alpha, an experimental immunotherapy, with paclitaxel (Taxol®) chemotherapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer who are planning to receive chemotherapy. You must not have yet received chemotherapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti), by injection, 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 6 months (standard of care)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti), by injection, 6-7 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for eftilagimod alpha (efti), by injection, 6 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 6 months (standard of care)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for eftilagimod alpha (efti), by injection, 6-7 months</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eftilagimod alpha (efti) is an experimental immunotherapy that activates the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug used to treat advanced breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05747794' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immutep.com/pipeline/clinical-pipeline.html#imp' target='_blank'>Immutep Drug Information Page: Eftilagimod Alpha (Efti)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

NEAREST SITE: 362 miles
Research Site
Long Beach,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05498155

Olaparib Targeted Therapy and Durvalumab Immunotherapy for Stage I-II ER-/ER Low, HER2-/HER2 Low Breast Cancer with a BRCA1/2 Mutation

A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor alone and with durvalumab (Imfinzi®) PD-L1 inhibitor before surgery (neoadjuvant).

Who is this for?

People with stage I or stage II estrogen receptor negative (ER-) or ER low, HER2 negative (HER2-) or HER2 low breast cancer with a BRCA1 or BRCA2 mutation who have not yet received treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 4-6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 4-6 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly for 4-6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05498155' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

NEAREST SITE: 374 miles
University of California - Irvine Medical Center
Orange,CA

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04180371

BT5528 Alone or With Nivolumab in Advanced Triple Negative Breast Cancer That Tests EphA2+

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of an experimental therapy called BT5528 when it is given alone or with nivolumab (Opdivo®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-), have already tried other cancer treatments, have no other standard treatment options, and have a tumor that tests positive for a protein called EphA2. Full eligibility criteria

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This trial is being conducted in two parts. You will participate in 1 of 2 parts depending on when you enroll: Part 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> </ul> Part 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 4 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528 targets a protein called EphA2 that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">EphA2 is found on some triple negative breast tumors. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04180371' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Information Page: BT5528</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/onc2017170' target='_blank'>Journal Article: Targeting EphA2 In Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/about-opdivo/how-opdivo-works-monotherapy' target='_blank'>Bristol-Meyers Squibb Information Page: Opdivo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/immunotherapy-2019/breast-cancer-gets-a-boost-from-immunotherapy' target='_blank'>Cure Today: Breast Cancer Gets a Boost From Immunotherapy</a> </li></ul>

NEAREST SITE: 374 miles
University of California Irvine
Irvine,CA

VISITS: May require hospitalization; 1 visit every 3 weeks for 2 years

PHASE: I

NCT ID: NCT05576077

TBio-4101 TIL Therapy with Pembrolizumab Immunotherapy for Advanced Breast Cancer

A Phase 1b Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab in Patients With Advanced Solid Tumor Malignancies (STARLING) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of TBio-4101, an experimental tumor infiltrating lymphocyte (TIL) therapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received standard treatment. Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101</li> <li class="seamTextUnorderedListItem">IL-2</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 3 weeks for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-4101 is an experimental immunotherapy called tumor infiltrating lymphocyte (TIL) therapy.</li> <li class="seamTextUnorderedListItem">TBio-4101 is made by collecting, growing, and modifying specialized immune cells that are collected from your tumor. The immune cells may recognize, target, and kill the tumor cells.</li> <li class="seamTextUnorderedListItem">Before you receive the immune cells, you will be treated with the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). This is to prepare your body to receive the enhanced immune cells.</li> <li class="seamTextUnorderedListItem">IL-2 is a type of immunotherapy that activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05576077' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://turnstonebio.com/#our-science' target='_blank'>Turnstone Biologics: TBio-4101 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-immune-targeted-therapies' target='_blank'>Breastcancer.org: Tumor Infiltrating Lymphocyte (TIL) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 437 miles
Research Site
Eugene,OR

VISITS: Approximately 1 visit a week

PHASE: I-II

NCT ID: NCT03742102

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA) Scientific Title

Purpose

To look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies.

Who is this for?

Women with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) being treated for the first time for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Capivasertib (AZD5363), by mouth, twice a day, 3 weeks on and 1 week off</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Danvatirsen (AZD9150), by IV, 3 times in the first week and then weekly</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Oleclumab (MEDI9447), by IV, once every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxol is a chemotherapy routinely used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742102' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>OncLive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/stat3-antisense-oligonucleotide-isis-481464' target='_blank'>NCI Drug Dictionary: Danvatirsen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd73-monoclonal-antibody-medi9447' target='_blank'>NCI Drug Dictionary: Oleclumab</a> </li></ul>

NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR

VISITS: Monthly visits for 1 year

PHASE: II

NCT ID: NCT03801369

Olaparib and Durvalumab in Metastatic Triple Negative & ER Low Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®).

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily for 1 month, then once a month for 1 year</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly, for 1 year</li> </ul> Additional procedures: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-3 tumor biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of ovarian cancer. </li> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy drug called a PD-L1 inhibitor. It gets the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of lung cancer. </li> <li class="seamTextUnorderedListItem">Preclinical studies suggest this drug combination may be effective in patients with metastatic triple negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03801369' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>Durvalumab (Imfinzi®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html?source=lyn_d_c_2&umedium=cpc&uadpub=google&ucampaign=lynparzadtcbranded_alone_2019&ucreative=branded_alone_ex&uplace=olapariblynparza&outcome=dtc&cmpid=1' target='_blank'>Olaparib (Lynparza®) Drug Information Page</a> </li></ul>

NEAREST SITE: 538 miles
Providence Cancer Institute - Franz Clinic
Portland,OR

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04120246

Alpha-TEA and Trastuzumab for Metastatic HER2 Positive Breast Cancer

A Phase I Dose Escalation Trial of Alpha-Tocopheryloxyacetic Acid (Î±-TEA) in Patients With Treatment Refractory HER2+ Metastatic Breast Cancer Scientific Title

Purpose

To study the best dose and effects (good and bad) of giving alpha-TEA in combination with trastuzumab (Herceptin®).

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received trastuzumab (Herceptin®), pertuzumab (Perjeta®), and trastuzumab emtansine/T-DM1 (Kadcyla®) for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpha-TEA, by mouth, daily (2 weeks on, 2 weeks off), ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> You will also receive your doctor's choice of hormone therapy if your tumor is hormone positive
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpha-TEA is a drug derived from vitamin E.</li> <li class="seamTextUnorderedListItem">Alpha-TEA may stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is commonly used to treat people with metastatic HER2 positive breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04120246' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/alpha-tocopheryloxyacetic-acid' target='_blank'>NCI Drug Dictionary: Alpha-Tocopheryloxyacetic Acid (Alpha-TEA)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>

NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR

VISITS: Approximately 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05163223

AST-301 Vaccine After Surgery for Stage I-III HR-, HER2 Low Breast Cancer

A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of AST-301, an experimental adjuvant (after surgery) vaccine.

Who is this for?

People with stage I, stage II, or stage III hormone receptor negative (ER- and/or PR-), HER2 low breast cancer with residual disease after neoadjuvant (before surgery) treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AST-301, by injection, every 3 weeks for 9 weeks plus a booster 6 months later</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks or capecitabine (Xeloda®), by mouth, 2 weeks on, 1 week off</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for AST-301, by injection, every 3 weeks for 9 weeks plus a booster 6 months later</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks or capecitabine (Xeloda®), by mouth, 2 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AST-301 is an experimental vaccine that may stimulate the immune system to attack and kill cancer cells that express HER2.</li> <li class="seamTextUnorderedListItem">AST-301 and the placebo for AST-301 include sargramostim (Leukine®) which helps the vaccine work better.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05163223' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pngvl3-hicd-vaccine-ast-301' target='_blank'>National Cancer Institute: AST-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/search?search=capecitabine' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/novel-her2-hicd-vaccine-to-be-investigated-for-treatment-of-her2-low-breast-cancer' target='_blank'>Targeted Oncology: Novel Vaccine to be Investigated for Treatment of HER2 Low Breast Cancer</a> </li></ul>

NEAREST SITE: 595 miles
South Texas Accelerated Research Therapeutics | START Rocky Mountain Region
West Valley City,UT

VISITS: 5 visits within 1 week, then 1-3 visits per month

PHASE: I

NCT ID: NCT05537740

BAY3375968 Immunotherapy with PD-1 Inhibitor for Advanced Triple Negative Breast Cancer

First-in-human Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Anti-CCR8 Antibody BAY 3375968 as Monotherapy and in Combination With Pembrolizumab in Participants With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BAY3375968, an experimental immunotherapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY3375968, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY3375968 is an experimental immunotherapy called a CCR8 inhibitor. mBAY3375968 binds to CCR8 on immune cells which allows the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05537740' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Abstract: BAY3375968</a> </li><li class='seamTextUnorderedListItem'><a href='https://aacrjournals.org/cancerres/article/82/12_Supplement/2866/704369' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05864144

SNS-101 With or Without Cemiplimab for Advanced Breast Cancer

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (Anti VISTA) as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and effects (good and bad) of SNS-101, an experimental immunotherapy, with or without cemiplimab, an experimental immunotherapy, in people with advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SNS-101, by IV, every 3 weeks</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SNS-101 is an anti-VISTA IgG1 monoclonal antibody. SNS-101 is an immune checkpoint inhibitor that may help other immunotherapies work better.</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) is a type of immunotherapy called an immune checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1. Cemiplimab is approved by the FDA for other cancers but it considered experimental for breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05864144' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.senseibio.com/wp-content/uploads/2022/05/SITC2022.pdf' target='_blank'>Sensei Biotherapeutics research poster: SNS-101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/cemiplimab-rwlc' target='_blank'>National Cancer Institute: Cemiplimab</a> </li></ul>

NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ

VISITS: 1 visit every 3 weeks, for 1 year

PHASE: II

NCT ID: NCT04197687

Immunotherapy and Sargramostim After Chemo and Surgery for Women with Stage II-III HER2 Positive Breast Cancer

Phase II Trial to Evaluate Immune-Related Biomarkers for Pathological Response in Stage II-III HER2-Positive Breast Cancer Receiving Neoadjuvant Chemotherapy With Subsequent Randomization to Multi-Epitope HER2 Vaccine vs. Placebo in Patients With Residual Disease Post-Neoadjuvant Chemotherapy Scientific Title

Purpose

To study the anti-cancer activity and effects (good and bad) of adding the vaccine TPIV100 and sargramostim to Trastuzumab emtansine/T-DM1 (Kadcyla®).

Who is this for?

Women with stage II or stage III HER2 positive (HER2+) breast cancer who have already received neoadjuvant (before surgery) chemotherapy and surgery. Full eligibility criteria

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If you had tumor cells remaining after you received chemotherapy, you will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, for 10.5 months</li> <li class="seamTextUnorderedListItem">TPIV100, by injection, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Sargramostim, by injection, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">2 boosters of TPIV100 and sargramostim after treatment, at 3 months and 1 year</li> </ul> Group 2: Standard Care and Placebo <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, for 10.5 months</li> <li class="seamTextUnorderedListItem">Placebo for TPIV100, by IV, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Placebo for sargramostim, by injection, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">2 placebo boosters of TPIV100 and sargramostim after treatment, at 3 months and 1 year</li> </ul> If you had no tumor cells remaining after you received chemotherapy, you will receive the following: Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, for 1 year</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, for 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPIV100 is an experimental vaccine. It may help the body build an immune response (go after) cancer cells that are HER2 positive (HER2+).</li> <li class="seamTextUnorderedListItem">Sargramostim is a drug approved for use during chemotherapy. It helps your body build white blood cells to prevent neutropenia--a low white blood cell count that increases your risk for infection. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2-targeted therapies used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">Kadcyla® is approved to treat some early-stage HER2 positive (HER2+) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04197687' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine/T-DM1 (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Therapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.markertherapeutics.com/pipeline/tpiv100/' target='_blank'>Drug Company Information Page: TPIV100</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/csf-meds-lower-neutropenia-risk' target='_blank'>Breastcancer.org: Colony-Stimulating Factor Medicines Slightly Lower Hospitalizations for Low White Blood Cell Counts</a> </li></ul>

NEAREST SITE: 666 miles
University of Washington
Seattle,WA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04841148

Preventing Stage II-III ER+, HER2- Breast Cancer with DTCs from Spreading

A Phase II Trial of Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer (PALAVY) Scientific Title

Purpose

To study if hydroxychloroquine (Plaquenil®) malaria drug and avelumab (Bavencio®) immunotherapy, with or without palbociclib (Ibrance®) targeted therapy, can prevent breast cancer from spreading.

Who is this for?

People with stage II or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who are receiving hormone therapy after surgery. You must have disseminated tumor cells (DTCs) in your bone marrow detected by the University of Pennsylvania. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks for 6 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 3 weeks on, 1 week off for 6 months</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disseminated tumor cells (DTCs) are single cancer cells that have moved from the tumor to somewhere else in the body, often the bone marrow.</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®) is a drug commonly used to prevent and treat malaria. It may also prevent cancer from spreading.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04841148' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://time.com/2870100/treating-cancer-with-a-malaria-drug/' target='_blank'>TIME: Hydroxychloroquine (Plaquenil®) for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Avelumab (Bavencio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li></ul>

NEAREST SITE: 682 miles
University of Washington / Fred Hutchinson Cancer Center
Seattle,WA

VISITS: 1 visit every 3 weeks, for 4.5 months before surgery

PHASE: II

NCT ID: NCT04584255

PARP Inhibitor & Experimental Immunotherapy Before Surgery for Stage I-III, HER2- Breast Cancer with an Inherited BRCA1/2 Mutation

A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of giving the experimental PARP inhibitor niraparib (Zejula®) in combination with the experimental PD-1 inhibitor TSR042 (dostarlimab).

Who is this for?

People with stage I, stage II or stage III, HER2 negative (HER2-) breast cancer with a tumor at least 1.5 cm and an inherited BRCA1/2 mutation who have not yet had surgery. Full eligibility criteria

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You will receive the following for 4.5 months before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily</li> <li class="seamTextUnorderedListItem">TSR042 (Dostarlimab), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It is approved for ovarian cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the enzyme poly (ADP-ribose) polymerase--this enzyme helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (TSR-042, Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04584255' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/niraparib.aspx' target='_blank'>Chemocare.com: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/tsr-042/' target='_blank'>Immuno-Oncology News: TSR-042 (Dostarlimab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zejula.com/en/hcp?cc=ps_2YZEQ6MXT1779794&mcm=220010&gclid=CjwKCAiA6aSABhApEiwA6Cbm_0dmoMN1fy65sxQRaJ4tJP5pyrjG7Zxa2N3W9SHd9XoaJLkymSF0NhoCy6EQAvD_BwE' target='_blank'>GSK Drug Information Page: Zejula® (Niraparib)</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 1 or 2 visits a week, for 3 months before surgery

PHASE: II

NCT ID: NCT04329065

WOKVAC Vaccine with Chemotherapy and Two Anti-HER2 Targeted Therapies Before Surgery for Stage I-III, HER2 Positive, HR Negative Breast Cancer

A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving the WOKVAC vaccine in combination with the chemotherapy paclitaxel (Taxol®) and the anti-HER2 targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) before surgery.

Who is this for?

People with stage I, stage II or stage III, HER2 positive (HER2+), hormone negative (ER- and PR-) breast cancer who have not yet had surgery. If you have already started chemotherapy before surgery, you will be allowed to enroll but will not receive the vaccine. Full eligibility criteria

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You will receive the following for three months before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC vaccine, by injection, 3 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week (2 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC is an experimental vaccine designed to stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is approved to treat early-stage HER2 positive breast cancer with tumors 2 cm or larger or with positive lymph nodes. It's use in this trial may be considered experimental depending upon the size of your tumors and if your lymph nodes are positive for cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04329065' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.wingsofkaren.org/dr-king---dr-disis' target='_blank'>Wings of Karen: WOKVAC Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/neoadjuvant-therapy/' target='_blank'>Susan G. Komen: Neoadjuvant Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/perjeta-plus-herceptin-and-chemo-shows-benefits' target='_blank'>Breastcancer.org: Adding Perjeta to Herceptin and Chemotherapy After Surgery Shows Benefits in Early-Stage HER2-Positive Breast Cancer</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 1 visit per month for 3 months, then 2 visits within 9 months

PHASE: II

NCT ID: NCT05455658

STEMVAC Vaccine for Stage I-III Triple Negative Breast Cancer

A Phase II Trial of The Immunogenicity of a DNA Plasmid Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDC25B, CD105) in Participants With Early Stage Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of the STEMVAC vaccine, an experimental immunotherapy, with sargramostim immunotherapy.

Who is this for?

People with some stage I (IB), stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have completed standard treatment between 1 month and 1 year ago. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STEMVAC vaccine, by injection, monthly for 3 months, then 2 times within 9 months</li> <li class="seamTextUnorderedListItem">Sargramostim, by injection, monthly for 3 months, then 2 times within 9 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The STEMVAC vaccine is an experimental immunotherapy that targets proteins on some breast cancer cells to boost the immune system to recognize and destroy some cancer cell proteins.</li> <li class="seamTextUnorderedListItem">Sargramostim is a type of immunotherapy that stimulates your body to produce more immune cells to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05455658' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uwcvi.org/post/2020-review-vaccine-and-clinical-trials' target='_blank'>University of Washington Cancer Vaccine Insititute: STEMVAC Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a693005.html' target='_blank'>MedlinePlus: Sargramostim</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 1 visit every week for 6 months, then 1 visit every 2-4 weeks

PHASE: I

NCT ID: NCT05098210

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine with immunotherapy.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received at least 1 line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly for 2 weeks</li> </ul> followed 2 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly, 3 weeks on, 1 week off</li> </ul> followed 6 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy. The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC is an immunotherapy that stimulates your immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05098210' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 735 miles
Cancer Care Northwest
Spokane Valley,WA

VISITS: May require hospitalization

PHASE: III

NCT ID: NCT06072612

Bria-IMT Cell Therapy for Advanced Breast Cancer

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer. Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of the Bria-IMT regimen, an experimental cell therapy, alone and with retifanlimab (Zynyz®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Bria-IMT Regimen with Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®), by infusion, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> Group 2: Bria-IMT Regimen Alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 day every 3 weeks</li> <li class="seamTextUnorderedListItem">SV-BR-1-GM, by injection, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Interferon, 4 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li> </ul> Group 3: Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> <li class="seamTextUnorderedListItem">Imaging scans, every 1-2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Bria-IMT regimen is an experimental cell therapy with SV-BR-1-GM cells.</li> <li class="seamTextUnorderedListItem">Before you receive the cell therapy, you will receive cyclophosphamide (Cytoxan®) chemotherapy to prepare your body to receive the cells.</li> <li class="seamTextUnorderedListItem">Interferon is an immunotherapy used to regulate your immune response to the cell therapy.</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06072612' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://briacell.com/briaimt/' target='_blank'>BriaCell Therapeutics: Bria-IMT Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/retifanlimab-dlwr' target='_blank'>National Cancer Institute: Retifanlimab (Zynyz®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 948 miles
Sarah Cannon Research Institute at HealthONE
Denver,CO

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04561362

Immunotherapy and BT8009 for Metastatic Breast Cancer that Expresses Nectin-4

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies Scientific Title

Purpose

To study the safety, anti-cancer activity, and effects (good and bad) of giving the experimental therapy BT8009 alone or in combination with the PD-1 inhibitor nivolumab (Opdivo®).

Who is this for?

People with metastatic (stage IV) breast cancer that expresses Nectin-4 and who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009 is an experimental therapy that targets Nectin-4, a protein expressed in some breast cancer cells, and delivers a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nectin-4 is often expressed in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Nectin-4</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04561362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-first-patient-dosed-phase-iii-0' target='_blank'>Press Release: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Drug Information Page: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Nectin' target='_blank'>Wikipedia: Nectin</a> </li></ul>

NEAREST SITE: 1398 miles
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls,SD

VISITS: 1-5 visits per month

PHASE: II

NCT ID: NCT05007106

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE-005) Scientific Title

Purpose

To study the effects and anti-cancer activity of MK-7684A, an experimental combination immunotherapy containing pembrolizumab and vibostolimab, alone and in combination with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have not received treatment with pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®). Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), by IV, for 5 consecutive days every 3 weeks</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, every 3 weeks</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-7684A is an experimental combination immunotherapy containing pembrolizumab and vibostolimab.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Vibostolimab is an experimental type of immunotherapy called a TIGIT inhibitor. Blocking TIGIT may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), cisplatin (Platinol®), and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05007106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/vibostolimab-pembrolizumab-mk-7684a?redirect=true' target='_blank'>National Cancer Institute: MK-7684A</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.annalsofoncology.org/article/S0923-7534(21)04776-1/fulltext' target='_blank'>Journal Article: Vibostolimab as Monotherapy or With Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/' target='_blank'>Merck Drug Information Page: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 1414 miles
XCancer Omaha / Urology Cancer Center
Omaha,NE

VISITS: 1 visit every 2 months for 8 months

PHASE: I

NCT ID: NCT05283330

Radiation Therapy for Metastatic HR+, HER2-, GRPR Expressing Breast Cancer

A Phase 1 Open-Label Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of 212Pb-DOTAM-GRPR1, an experimental radiation therapy.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that expresses GRPR who have not received whole body radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">212Pb-DOTAM-GRPR1, every 2 months for 8 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">212Pb-DOTAM-GRPR1 is an experimental radiation therapy called a radioimmunoconjugate, which is a radioactive substance that carries radiation directly to cancer cells.</li> <li class="seamTextUnorderedListItem">A radioimmunoconjugate is a type of radiation therapy that combines an antibody that targets cancer cells with a radiation therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">212Pb-DOTAM-GRPR1 contains a GRPR inhibitor. Inhibiting GRPR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: GRPR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05283330' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/radioimmunoconjugate' target='_blank'>National Cancer Institute: Radioimmunoconjugate</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oranomed.com/en/pipeline' target='_blank'>Orano Med LLC: 212Pb-DOTAM-GRPR1 Drug Information Page</a> </li></ul>

NEAREST SITE: 1471 miles
NEXT Dallas
Irving,TX

VISITS: 1 visit every 2 weeks for 1 year

PHASE: I

NCT ID: NCT06014502

IMGS-001 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients With Relapsed or Refractory Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of IMGS-001, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMGS-001, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMGS-001 is an experimental immunotherapy that targets PD-L1 and PD-L2.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06014502' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunogenesis.com/science/' target='_blank'>ImmunoGenesis: What is IMGS-001?</a> </li></ul>

NEAREST SITE: 1471 miles
NEXT Oncology, Dallas
Dallas,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05746897

NM1F and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of NM1F as Monotherapy and in Combination With Pembrolizumab in Subjects With Locally Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of two immunotherapy drugs, NM1F and pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer whose cancer has progressed on standard treatments. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM1F, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM1F is a type of immunotherapy called a PVRIG inhibitor that may work better when combined with pembrolizumab (Keytruda®). Blocking PVRIG may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05746897' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.pharmabiz.com/NewsDetails.aspx?aid=155259&sid=2' target='_blank'>Pharmabiz: NM1F</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li></ul>

NEAREST SITE: 1478 miles
Mary Crowley Cancer Research
Dallas,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06299163

NM32-2668 Trispecific Antibody for Advanced ROR Expressing Breast Cancer

A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of NM32-2668, an experimental trispecific antibody.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) ROR expressing breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM32-2668</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NM32-2668 is an experimental immunotherapy called a trispecific antibody.</li> <li class="seamTextUnorderedListItem">A trispecific antibody binds to 3 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">NM32-2668 is a bispecific antibody that targets ROR1, CD3, and HSA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06299163' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://numab.com/pipeline/' target='_blank'>Numab Therapeutics: NM32-2668 Drug Information Page</a> </li></ul>

NEAREST SITE: 1479 miles
Texas Oncology, P.A.
Dallas,TX

VISITS: 1-5 visits every month

PHASE: I

NCT ID: NCT05029999

2 Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of CDX-301 and CDX-1140, two experimental types of immunotherapy, with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and have received 0-2 lines of therapy for advanced disease. You must not have received treatment with Adriamycin® (doxorubicin) or Doxil® (doxorubicin) chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month, starting month 2</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 days every month for 2 months</li> <li class="seamTextUnorderedListItem">CDX-1140, by injection, every month, starting month 2</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, every month</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDX-301 and CDX-1140 are experimental types of immunotherapy that allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CDX-301 increases immune cells and CDX-1140 activates immune cells that are needed to kickstart the immune response.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug. It trains immune cells to recognize the cancer for the immune system to attack it.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05029999' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://celldex.com/pipeline/overview/' target='_blank'>Celldex Therapeutics Drug Information Page: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-cdx-1140' target='_blank'>National Cancer Institute: CDX-1140</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-cdx-301-safely-mobilizes-hematopoietic' target='_blank'>Celldex Therapeutics Press Release: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology /ID# 208930
San Antonio,TX

VISITS: 1 visit every month, ongoing

PHASE: I

NCT ID: NCT03821935

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To investigate the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has been treated with at least one systemic therapy. Full eligibility criteria

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You will be assigned to 1 of the 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. </li> <li class="seamTextUnorderedListItem">ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to see and go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03821935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-151.html' target='_blank'>Drug company information page: ABBV-151</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-oncology news: ABBV-181</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06052852

BDC-3042 Targeted Therapy for Metastatic Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-3042 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BDC-3042, an experimental dectin-2 inhibitor, alone and with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042, by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042, by IV</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BDC-3042 is an experimental targeted therapy called a dectin-2 inhibitor. Blocking dectin-2 stimulates the immune system's ability to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06052852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boltbio.com/pipeline-new/#bdc-3042' target='_blank'>Bolt Biotherapeutics: BDC-3042 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pennmedicine.org/news/news-releases/2019/january/energizing-the-immune-system-to-eat-cancer' target='_blank'>University of Pennsylvania: Awakening Immune Cells Called Macrophages to Kill Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/?utm_medium=email&utm_source=subscribers&utm_campaign=Oct2023&utm_content=Email102023' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 1481 miles
Mays Cancer Center at UT Health San Antonio
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04849364

Chemotherapy, Immunotherapy, and/or Targeted Therapy to Prevent Recurrence of Triple Negative Breast Cancer That is ctDNA Positive

A Phase II Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (PERSEVERE) Scientific Title

Purpose

To study if chemotherapy, immunotherapy, and/or targeted therapy after neoadjuvant chemotherapy and surgery helps prevent recurrence.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer that is ctDNA positive. You must have received chemotherapy before surgery (neoadjuvant). If you received a lumpectomy or partial mastectomy, you must have also received radiation. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (GDC-0077), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), 6 months</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off, 6 months</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will be assigned to a group based on ctDNA testing and genetic testing results.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) and pembrolizumab (Keytruda®) are a type of immunotherapy called a PD-1/PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1/PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Inavolisib (GDC-0077) is an experimental targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 negative is defined as IHC 0 to 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04849364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancer.iu.edu/patients/research-explained/breast/persevere.html' target='_blank'>Indiana University: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>

NEAREST SITE: 1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas,TX

VISITS: Number of visits unavailable, ongoing

PHASE: NA

NCT ID: NCT04265872

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or ER Low Breast Cancer

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of first giving bortezomib (Velcade®), then giving pembrolizumab (Keytruda®) and cisplatin (Platinol®).

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have not received more than three chemotherapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®), by IV</li> <li class="seamTextUnorderedListItem">followed by, pembrolizumab (Keytruda®) and cisplatin (Platinol®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®) is a type of targeted therapy called a protease inhibitor. It is approved for use in some other cancers but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved for use in some cancers but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy commonly used for metastatic triple negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04265872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Bortezomib' target='_blank'>Wikipedia: Bortezomib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.velcade.com/about-velcade/faq' target='_blank'>Takeda Pharmaceutical Company Drug Information Page: Velcade® (Bortezomib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/86804' target='_blank'>MedPage Today: Pembrolizumab May Help in Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncobites.blog/2020/02/07/cisplatin-a-journey-to-a-solution-for-triple-negative-breast-cancer/' target='_blank'>OncoBites Blog: Cisplatin--A Journey to a Solution for Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1498 miles
NEXT Austin
Austin,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06270706

PLN-101095 Immunotherapy with Pembrolizumab for Advanced Breast Cancer

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembro... Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PLN-101095, an experimental immunotherapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. You must have received pembrolizumab (Keytruda®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PLN-101095</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PLN-101095 is an experimental immunotherapy. PLN-101095 may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06270706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://pliantrx.com/oncology/' target='_blank'>Pliant Therapeutics: PLN-101095 Drug Information Page</a> </li></ul>

NEAREST SITE: 1499 miles
The University of Kansas Cancer Center - Overland Park
Overland Park,KS

VISITS: 1 visit every 2-3 weeks for 3-4.5 months

PHASE: II

NCT ID: NCT05645380

Chemoimmunotherapy Before Surgery for Women with Stage I-III Triple Negative Breast Cancer

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC Scientific Title

Purpose

To study if the number of immune cells in and around tumors impacts tumor response to neoadjuvant (before surgery) chemoimmunotherapy and can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy.

Who is this for?

Women 18-70 years old with stage I, stage II, or some stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on your situation: Group 1: High/Intermediate Number of Immune Cells <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3-4.5 months</li> </ul> Group 2: Low Number of Immune Cells <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 2-3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumb (Keytruda®), by IV, every 2-3 weeks for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemoimmunotherapy is chemotherapy combined with immunotherapy.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), docetaxel (Taxotere®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Triple negative breast cancer (TNBC) with more immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better outcomes.</li> <li class="seamTextUnorderedListItem">Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment.</li> <li class="seamTextUnorderedListItem">Tumor disappearance seen by imaging scans after chemoimmunotherapy usually means that the tumor will have completely disappeared by surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05645380' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/search?search=carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxotere' target='_blank'>Breastcancer.org: Docetaxel (Taxotere®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/adriamycin' target='_blank'>Breastcancer.org: Doxorubicin (Adriamycin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 1509 miles
UT Southwestern Medical Center
Dallas,TX

VISITS: Number of visits vary, over 5 months

PHASE: II

NCT ID: NCT03804944

Radiation Therapy With or Without Immunotherapy Before Surgery in Women with Stage II-III, ER+, HER2- Breast Cancer

Converting HR+ Breast Cancer Into an Individualized Vaccine Scientific Title

Purpose

To study the anti-cancer activity and safety of giving hypofractionated radiation therapy and anti-hormone therapy with or without immunotherapy before surgery.

Who is this for?

Postmenopausal women newly diagnosed with stage II or stage III, estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups, and receive the following over 4 months before surgery: Group 1: Radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypo-fractionated radiation therapy, 3 times a week, for one week</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, until surgery</li> </ul> Group 2: Radiation therapy and PD-1 inhibitor immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypo-fractionated radiation therapy, 3 times a week, for one week</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, until surgery</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, until surgery</li> </ul> Group 3: Radiation therapy and CDX-301 immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypo-fractionated radiation therapy, 3 times a week, for one week</li> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 times a week, for one week</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, until surgery</li> </ul> Group 4: Radiation therapy, PD-1, and CDX-301 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hypo-fractionated radiation therapy, 3 times a week, for one week</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, until surgery</li> <li class="seamTextUnorderedListItem">CDX-301, by injection, 5 times a week, for one week</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, until surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy may trigger an immune response that acts like an individualized vaccine. This may help prevent recurrence (your cancer coming back). </li> <li class="seamTextUnorderedListItem">Hypofractionated radiation therapy is when fewer, but larger, doses of radiation are given. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, it gets the immune system to see and go after cancer cells.</li> <li class="seamTextUnorderedListItem">While pembrolizumab is approved to treat many types of cancers, including some types of breast cancer, its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">CDX-301 is an experimental immunotherapy that research suggests may help your immune system go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03804944' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/videos/2017-san-antonio-breast-cancer-symposium/keynote-lecture-silvia-c-formenti-md-on-converting-tumors-into-in-situ-vaccines-with-radiation-therapy/' target='_blank'>The ASCO Post: Converting Tumors Into in Situ Vaccines With Radiation Therapy (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hypofractionated-radiation-therapy' target='_blank'>NCI Dictionary of Cancer Terms: Hypofractionated radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/oncolog/radiation-may-enhance-immunotherapy-for-solid-tumors.h10-1591413.html' target='_blank'>MD Anderson Cancer Center: Radiation May Enhance Immunotherapy for Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celldex.com/pipeline/cdx-301.php' target='_blank'>Celldex Therapeutics Drug Information Page: CDK-301</a> </li></ul>

NEAREST SITE: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX

VISITS: 3 visits every 1.5 months

PHASE: I

NCT ID: NCT06022029

ONM-501 Targeted Therapy for Advanced Breast Cancer

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ONM-501, an experimental STING inhibitor, alone and with cemiplimab (Libtayo®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501, by injection, 3 times every 1.5 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501, by injection, 3 times every 1.5 months</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONM-501 is an experimental targeted therapy called a STING inhibitor. Blocking STING may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06022029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onconano.com/our-technology/' target='_blank'>OncoNano Medicine: ONM-501 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618054.html' target='_blank'>Medline Plus: Cemiplimab (Libtayo®)</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: 1 visit every 3 weeks for 2.5 months

PHASE: I

NCT ID: NCT04521764

A Vaccine Injected Directly Into a Tumor for Metastatic Breast Cancer

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To study the best dose, safety, and anti-cancer activity of an experimental vaccine that is injected directly into the tumor.

Who is this for?

People with metastatic (stage IV) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MV-s-NAP vaccine, by injection directly into your tumor, every 3 weeks, 4 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MV-s-NAP is the name of the vaccine used in this trial. It is made from a modified measles virus.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04521764' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.webmd.com/breast-cancer/metastatic-breast-cancer-vaccine-treatment' target='_blank'>WebMD: Vaccine Treatment for Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic in Rochester
Rochester,MN

VISITS: Every 2 weeks, for 2 months

PHASE: I

NCT ID: NCT04144023

Vaccine Before Surgery for HER2-Expressing DCIS

A Phase IB Trial of Neoadjvuant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS Scientific Title

Purpose

To study the best dose, safety, and effects (good and bad) of a HER2 vaccine called H2NVAC.

Who is this for?

Women with DCIS that is HER2-expressing and who have not have had any other treatments for this DCIS. Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 vaccine H2NVAC, by injection, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">GM-CSF, by injection, once every 2 weeks for 2 months</li> </ul> Additional procedure <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving the H2NVAC vaccine before surgery allows researchers to study the effect that it has on cancer cells. </li> <li class="seamTextUnorderedListItem">Cancer vaccines are a type of immunotherapy. They are designed to teach the immune system to see and kill cancer cells.</li> <li class="seamTextUnorderedListItem">HER2-expressing DCIS will have an immunohistochemistry of +1, +2, or +3.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04144023' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/what-are-cancer-vaccines' target='_blank'>ASCO Cancer.net: What are Cancer Vaccines?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/forefront/researchers-testing-vaccine-against-dcis' target='_blank'>Mayo Clinic: Vaccine for DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.youtube.com/watch?v=-gJfkmv5ZIs' target='_blank'>Dr. Susan Love Research Foundation: Breast Cancer Vaccines (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/immunotherapy/treatment-types/cancer-vaccines' target='_blank'>Cancer Research Institute: Cancer Vaccines, Preventive, Therapeutic, Personalized</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic - Rochester
Rochester,MN

VISITS: 1 visit a week, for 6 months to 1 year

PHASE: II

NCT ID: NCT04443348

Radiation Therapy, Chemotherapy, and Immunotherapy Before Surgery for Stage II-III HER2 Negative, Node Positive Breast Cancer

P-RAD: A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of giving radiation therapy, immunotherapy, and chemotherapy before surgery, and immunotherapy and chemotherapy after surgery.

Who is this for?

People with stage II or stage III HER2-negative breast cancer with at least 1 positive lymph node. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following for up to 1 year: Group 1: Without radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks, for 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and doxorubicin (Adriamycin®), by IV, every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">followed by surgery</li> <li class="seamTextUnorderedListItem">followed by your doctor's choice of pembrolizumab, by IV, every 6 weeks, for another 5.5 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding capecitabine (Xeloda®)</li> </ul> Group 2: With radiation therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy, once a day, 3 days in a row</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks, for 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and doxorubicin (Adriamycin®), by IV, every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">followed by surgery</li> <li class="seamTextUnorderedListItem">followed by your doctor's choice of pembrolizumab, by IV, every 6 weeks, for another 5.5 months</li> <li class="seamTextUnorderedListItem">Your doctor's choice of adding capecitabine (Xeloda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, it gets the immune system to go after cancer cells. It is approved to treat many types of cancers, including some types of breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), cyclophosphamide (Cytoxan®), and doxorubicin (Adriamycin®) are chemotherapies commonly used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and capecitabine (Xeloda®) are chemotherapies commonly used to treat triple-negative (ER-, PR-, HER2-) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04443348' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/keytruda-plus-chemo-before-sx-for-early-tnbc' target='_blank'>Breastcancer.org: Adding Keytruda to Chemotherapy Before Surgery for Early-Stage, Triple-Negative Breast Cancer Improves Response to Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20191205/pembrolizumab-plus-radiotherapy-safe-active-in-metastatic-triplenegative-breast-cancer' target='_blank'>Healio: Pembrolizumab Plus Radiotherapy Safe, Active in Metastatic Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05700721

Niraparib and Dostarlimab for Metastatic Triple-Negative or BRCA1/2 Mutant Breast Cancer that has Spread to the Brain

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of the combination of niraparib (Zejula®), a PARP inhibitor, and dostarlimab (Jemperli®), an immunotherapy, to control breast cancer that has spread to the brain.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or BRCA1/2 mutated breast cancer that has spread to the brain (brain metastasis). You must have received at least one standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05700721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 1643 miles
Baylor St. Luke's Medical Center
Houston,TX

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT03740256

CAR-T Cell Immunotherapy & Immunotherapy Injected Directly into Tumors for Metastatic HER2 Positive Breast Cancer

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and other effects (good and bad) of giving a HER2-specific CAR-T Cell immunotherapy and an immunotherapy injected directly into a tumor.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAdVEC, by injection directly into a tumor, one time</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2-specific CAR-T Cell therapy, by IV, one time</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">CAdVEC is an oncolytic adenovirus--this means it targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">CAdVEC is injected directly into a tumor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2 positive cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03740256' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&version=20.07d&code=C158743&ns=ncit&type=all&key=null&b=1&n=0&vse=null' target='_blank'>NCI Thesaurus: CAdVEC</a> </li></ul>

NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: At least 8 visits within 6 months, then 1 visit every 6 months after surgery

PHASE: II

NCT ID: NCT05795101

TRUDI: Trastuzumab Deruxtecan ADC and Durvalumab Immunotherapy for Stage III HER2+ or HER2 Low Inflammatory Breast Cancer

TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with durvalumab (Imfinzi®) PD-1 inhibitor.

Who is this for?

People with newly diagnosed stage III HER2 positive (HER2+) or HER2 low inflammatory breast cancer who have not yet received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Chest X-rays, every 1.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertru®) has been approved to treat HER2+ and HER2 low breast cancer. Its use in inflammatory breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) has been approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+ and ISH- or ISH untested.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05795101' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/durvalumab' target='_blank'>Cancer Research UK: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05092373

Tumor Treating Fields Device for Advanced Breast Cancer

Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib, or With Atezolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of Tumor Treating Fields (TTF), an experimental wearable device, with targeted therapy or chemotherapy and immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: TTF with Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®), by mouth, daily</li> </ul> Group 2: TTF with Chemotherapy and Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF) consists of experimental wearable devices that use electrical fields at different frequencies to stop the growth of tumor cells by interrupting cancer cells' ability to divide.</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®) is a type of targeted therapy called a tyrosine kinase inhibitor. Tyrosine kinase inhibitors work by blocking proteins that signal cancer cells to multiply, which may help keep cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a type of chemotherapy drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05092373' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/tumor-treating-fields-ttf-4584149' target='_blank'>Verywell Health: Tumor Treating Fields (TTF)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>MedlinePlus: Cabozantinib (Cabometyx® or Cometriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/tecentriq' target='_blank'>Breastcancer.org: Atezolizumab (Tecentriq®)</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05064280

Pembrolizumab and Lenvatinib for People with Breast Cancer Brain Metastases

Phase II Study of Pembrolizumab in Combination With Lenvatinib in Patients With TNBC, NSCLC, and Other Tumor Types and Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor and pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05064280' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT05675579

Sacituzumab Govitecan ADC and Pembrolizumab Immunotherapy Before Surgery for Stage I-III Triple Negative Breast Cancer

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) sacituzumab govitecan (Trodelvy®) antibody drug conjugate (ADC) and pembrolizumab (Keytruda®) PD-1 inhibitor for triple negative breast cancer that has not responded well to other treatments.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER low, PR low, HER2 negative (HER2-) breast cancer who are receiving neoadjuvant (before surgery) pembrolizumab (Keytruda®) with paclitaxel (Abraxane®) and carboplatin (Paraplatin®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off, for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, weekly for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">In this trial, ER low and PR low are defined as between 1-10%.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05675579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</a> </li></ul>

NEAREST SITE: 1835 miles
Carle Cancer Center
Urbana,IL

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05207709

CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy with ribociclib (Kisqali®) or palbociclib (Ibrance®) CDK4/6 inhibitors.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER2 enriched or Basal like breast cancer. You must not have received treatment with chemotherapy for advanced disease or any CDK4/6 inhibitors. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1: HER2 Enriched Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> Group 2: HER2 Enriched Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> Group 3: Basal Like Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) with or without tislelizumab</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and palbociclib (Ibrance®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) test will determine if you have HER2 enriched or Basal like breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05207709' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/our-science-and-medicines/tislelizumab/' target='_blank'>Beigene: Tislelizumab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/diagnosis/molecular-subtypes/' target='_blank'>Susan G. Komen: HER2-Enriched and Basal-Like Breast Cancer</a> </li></ul>

NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL

VISITS: Number of visits unavailable, for 3 weeks before surgery

PHASE: I

NCT ID: NCT04427293

Targeted Therapy & Immunotherapy Before Surgery for Women with Stage I-II Triple Negative or ER Low Breast Cancer

BRE-03: Window of Opportunity Trial of Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the anti-cancer activity and side effects of giving the targeted therapy lenvatinib (Lenvima®) and the immunotherapy pembrolizumab (Keytruda®) before surgery.

Who is this for?

Women with stage I or stage II triple negative (ER-, PR-, HER2-) or HER2 negative (HER2-) and ER Low (1%-10% ER) breast cancer who have not yet started treatment. Full eligibility criteria

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You will receive the following for three weeks before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily, for 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a targeted therapy that blocks vascular endothelial growth factor receptor 2 (VEGFR2).</li> <li class="seamTextUnorderedListItem">It is approved for certain types of thyroid, kidney and liver cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple negative breast cancers, but its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04427293' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/lenvatinib.aspx' target='_blank'>Chemocare.com: Lenvatinib</a> </li></ul>

NEAREST SITE: 1856 miles
Northwestern University
Chicago,IL

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03213041

Keytruda with Chemotherapy for Treating HER2- Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC) Scientific Title

Purpose

To determine the safety and effects (good and bad) of treating HER2-negative metastatic breast cancer with an immunotherapy drug along with a chemotherapy drug.

Who is this for?

People with metastatic (stage IV) breast cancer that is HER2 negative. If you are estrogen receptor positive, you must have progressed on available endocrine therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for up to 2 years</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is pembrolizumab (Keytruda®). It is a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">The chemotherapy drug is carboplatin (Paraplatin®). It is used to treat metastatic breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03213041' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: 2 visits every 3 weeks

PHASE: II

NCT ID: NCT04468061

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy) alone and in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or ER Low (1%-10% ER), HER2 negative breast cancer that is PD-L1 negative, who have not yet started treatment for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple negative as well as ER Low, HER2 negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>

NEAREST SITE: 1944 miles
IU Health Joe and Shelly Schwarz Cancer Center
Carmel,IN

VISITS: 1-2 visits every month

PHASE: II

NCT ID: NCT05846789

Chemotherapy Alone or With Immunotherapy for Advanced Triple Negative, PD-L1 Negative Breast Cancer

A Phase II Trial of Carboplatin +/- Tocilizumab as Initial Therapy for Metastatic Triple Negative and ER-low Breast Cancers Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of carboplatin (Paraplatin®) chemotherapy alone or with tocilizumab, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR-, HER2- or HER2 low), PD-L1 negative breast cancer who have not received chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tocilizumab, by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tocilizumab is an experimental immunotherapy called an IL-6 inhibitor that is approved to treat arthritis. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ and FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05846789' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/carboplatin' target='_blank'>Breastcancer.org: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a611004.html' target='_blank'>MedlinePlus: Tocilizumab</a> </li></ul>

NEAREST SITE: 1959 miles
SCRI Oncology Partners Sarah Cannon new location
Nashville,TN

VISITS: 1 visit every month

PHASE: I

NCT ID: NCT05544929

KFA115 Immunotherapy Alone and With Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of KFA115, an experimental immunotherapy, alone or with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115, monthly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KFA115 is an experimental immunotherapy.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05544929' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/research-development/novartis-pipeline?search_api_fulltext=KFA115' target='_blank'>Novartis Pharmaceuticals: KFA115 Drug Information Page</a> </li></ul>

NEAREST SITE: 1985 miles
Baptist Health Clinical Research
Elizabethtown,KY

VISITS: At least 2 visits over 6-8 weeks

PHASE: NA

NCT ID: NCT05037825

How the Gut Microbiome May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors Scientific Title

Purpose

To study the gut microbiome to see if it can determine if immunotherapy will be effective.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative breast cancer (ER-, PR- and HER2-) who are about to begin treatment with a checkpoint inhibitor (immunotherapy). You must speak English or Spanish. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 blood tests over 6-8 weeks</li> <li class="seamTextUnorderedListItem">2 stool samples over 6-8 weeks</li> <li class="seamTextUnorderedListItem">Questionairres (in English or Spanish)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome may help determine if immunotherapy will be effective. </li> <li class="seamTextUnorderedListItem">By studying the microbiome, researchers may also be able to determine if changing the microbiome through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, can help the immune system fight cancer.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) are a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05037825' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2013 miles
University of Alabama at Birmingham
Birmingham,AL

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04711824

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?

Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: May require hospitalization; 4-7 visits every month

PHASE: I-II

NCT ID: NCT06026657

Gemcitabine Chemotherapy and NK Cell Therapy for Metastatic HER2 Negative Breast Cancer

Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of gemcitabine (Gemzar®) chemotherapy and NK cell therapy with or without naxitamab (Danyelza®) targeted therapy.

Who is this for?

People with stage IV (metastatic) HER2 negative (HER2-) breast cancer who have received at least 1 line of therapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, monthly, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy, by IV, 2 times every month, up to 1 year</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug that blocks cancer cells from making DNA which may kill cancer cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is a type of targeted therapy called a GD2 inhibitor. GD2 inhibitors help your immune system attack tumor cells.</li> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®) is approved to treat people with other types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">TGFBi NK cell therapy is an experimental immunotherapy. NK cells are part of your natural immune system and can identify cancer cells and help your immune system kill cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06026657' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621005.html#:~:text=Naxitamab%2Dgqgk%20injection%20is%20used,have%20responded%20to%20other%20treatments.' target='_blank'>Medline Plus: Naxitamab (Danyelza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/body/24898-natural-killer-cells' target='_blank'>Cleveland Clinic: NK Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

NEAREST SITE: 2127 miles
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland,OH

VISITS: 3 visits within 1 month

PHASE: NA

NCT ID: NCT04674306

Alpha-lactalbumin Vaccine for Triple Negative Breast Cancer

Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of an alpha-lactalbumin vaccine (aLA) vaccine, an experimental immunotherapy.

Who is this for?

People with stage II or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have completed treatment within the last 3 years. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpha-lactalbumin vaccine (aLA) vaccine plus Zymosan, by injection, 3 times within 1 month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The alpha-lactalbumin vaccine (aLA) vaccine is an experimental immunotherapy that may stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Zymosan enhances your body's immune response.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04674306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/dosing-of-cleveland-clinic-s--lactalbumin-vaccine-begins-in-phase-1-breast-cancer-study' target='_blank'>TargetedOnc: Alpha-lactalbumin Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li></ul>

NEAREST SITE: 2139 miles
Emory University/Winship Cancer Institute
Atlanta,GA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05877859

Response to Chemo and Immunotherapy Before Surgery for Women with Stage II-III Triple Negative Breast Cancer

Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab Scientific Title

Purpose

To study the immune response to treatment with standard of care chemotherapy given with the immunotherapy pembrolizumab (Keytruda®) before surgery.

Who is this for?

Women with newly diagnosed stage II or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have not yet received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care neoadjuvant (before surgery) chemotherapy with pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemo-immunotherapy is the combination of chemotherapy and immunotherapy.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05877859' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/triple-negative' target='_blank'>Breastcancer.org: Treatment for Triple Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 2139 miles
Emory University
Atlanta,GA

VISITS: 3 visits over 2 months

PHASE: I

NCT ID: NCT02977468

Neoadjuvant Keytruda and Radiation Therapy for Stage I-III, Triple Negative or ER Low, HER2- Breast Cancer

Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT: a Window of Opportunity Study Scientific Title

Purpose

To study how pembrolizumab (Keytruda®) affects cancer cells, the healthy tissue surrounding tumors (the microenvironment), the immune system, and intraoperative radiation therapy.

Who is this for?

Women with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer who have not yet received any treatment for their cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 or 2 times before surgery</li> </ul> Followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Intraoperative radiation therapy (IORT) during surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving a drug before surgery allows doctors to study its effects. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat certain types of breast cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">The radiation treatment, called intraoperative radiation therapy (IORT), delivers a high dose of radiation to the area where the tumor was removed.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02977468' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/News/20659' target='_blank'>ASCO Post: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation/intraoperative' target='_blank'>Breastcancer.org: Intraoperative Radiation Therapy (IORT)</a> </li></ul>

100

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: 6 visits within 2 weeks, then 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05756166

CKM Therapy with Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of chemokine modulation (CKM) therapy with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose cancer progressed on prior treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®), by mouth, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®), by IV, 6 times within 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemokine modulation (CKM) therapy is a type of immunotherapy that involves rintatolimod (Ampligen®), celecoxib (Celebrex®), and interferon alpha 2b (Bioferon®).</li> <li class="seamTextUnorderedListItem">Rintatolimod (Ampligen®) is a drug for chronic fatigue syndrome that may also stimulate the immune system to fight cancer cells.</li> <li class="seamTextUnorderedListItem">Celecoxib (Celebrex®) is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels that tumors need to grow and spread.</li> <li class="seamTextUnorderedListItem">Interferon alpha 2b (Bioferon®) helps the immune system fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">CKM therapy may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05756166' target='_blank'>ClinicalTrials.gov</a> </li></ul>

101

NEAREST SITE: 2299 miles
Levine Cancer Institute
Charlotte,NC

VISITS: 1 visit every 1-2 weeks

PHASE: II

NCT ID: NCT06027268

Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer

ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer. You must not have received more than 3 lines of chemotherapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the bone marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>

102

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04348747

Dendritic Cell Vaccine and Pembrolizumab for Metastatic Triple Negative and HER2+ Breast Cancer With Brain Metastasis

A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) and progressed on standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for 3 sessions (potential additional sessions every 3 months)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 brain MRI</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the brain is called brain metastasis.</li> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an experimental type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04348747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org: About Breast Cancer Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy' target='_blank'>Roswell Park Comprehensive Cancer Center Press Release: Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer</a> </li></ul>

103

NEAREST SITE: 2351 miles
University of Florida
Gainesville,FL

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT05000294

Atezolizumab With Tivozanib for Metastatic Hormone Negative, HER2 Positive Breast Cancer

Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of atezolizumab (Tecentriq®) immunotherapy given together with tivozanib (Fotivda®) immunotherapy.

Who is this for?

People with metastatic (stage IV) hormone negative (ER-/PR-), HER2 positive (HER2+) breast cancer who have received at least three lines of therapy and have not received treatment with immunotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 4 weeks</li> <li class="seamTextUnorderedListItem">Tivozanib (Fotivda®), by mouth, daily, 3 weeks on, 1 week off</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Tivozanib (Fotivda®) is a type of immunotherapy called a VEGFR inhibitor. Blocking VEGFR may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">You must not have received treatment with immunotherapy: pembrolizumab (Keytruda®), atezolizumab (Tecentriq®), or ipilimumab (Yervoy®).</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05000294' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/' target='_blank'>Genentech Drug Information Page: Atezolizumab (Tecentriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fotivda.com/' target='_blank'>Aveo Oncology Drug Information Page: Tivozanib (Fotivda®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://investor.aveooncology.com/news-releases/news-release-details/aveo-oncology-presents-three-posters-tivozanibimmunotherapy' target='_blank'>Aveo Oncology Press Release: Atezolizumab (Tecentriq®) with ivozanib (Fotivda®)</a> </li></ul>

104

NEAREST SITE: 2376 miles
Ashley Donihee
Charlottesville,VA

VISITS: 1-2 visits a week for 7 weeks, may require hospitalization

PHASE: I-II

NCT ID: NCT03272334

A T-Cell Immunotherapy (HER2 BATs) and Keytruda for Women With Metastatic Breast Cancer

A Phase I/II Study of Anti-CD3 x Anti-HER2/Neu (Her2Bi) Armed Activated T Cells (ATC) and Pembrolizumab Combination Therapy in Women With Metastatic Breast Cancer Scientific Title

Purpose

To investigate the safety and effects (good and bad) of combining the PD-1 inhibitor Keytruda with an immunotherapy made from your T-cells.

Who is this for?

Women with metastatic (stage IV) breast cancer. You must have had two or more prior therapies (chemotherapy or hormonal) for metastatic disease. Full eligibility criteria

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What's being studied?
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You will receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once during week 7</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice, during week 3-4 and week 7</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (leukapheresis), then 4 to 5 weeks later</li> <li class="seamTextUnorderedListItem">T-cell immunotherapy (HER2 BATs), by IV, 8 times over 6 weeks </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, three times, before BATs, during week 3-4 and week 7</li> </ul> Please contact research site for treatment schedule. May require hospitalization
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">HER2 bispecific antibody armed T cells (BATs) are an experimental type of T-cell immunotherapy. </li> <li class="seamTextUnorderedListItem">The HER2 BATs will be made by collecting white blood cells from your body. Your white blood cells will then be modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03272334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2bi-armed-activated-t-cells' target='_blank'>NCI Drug Dictionary: HER2Bi-armed ATCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4839366/' target='_blank'>OncoImmunology: HER2 BATs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwt-L2BRA_EiwAacX32ZWZ-hf-RSddVt1Y8_oFJEJzejiyhC9eCFhl1JG4WlqWBf2Aq3rrXhoCf7AQA' target='_blank'>Merck Oncology Drug Information Page: Keytruda®</a> </li></ul>

105

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: 5 visits in 3 weeks, then 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05269381

Personalized Vaccine with Pembrolizumab for Advanced Breast Cancer

A Phase I Pilot Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a personalized neoantigen peptide vaccine, an experimental type of immunotherapy, with pembrolizumab (Keytruda®), a type of immunotherapy called a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that have received at least 1 line of standard treatment. If you have triple negative (ER-, PR-, HER2-) breast cancer, you must currently be receiving treatment with pembrolizumab (Keytruda®). Full eligibility criteria

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 1 session</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Sargramostim, by injection, 4 times in 2 weeks, then every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require at least 1 biopsy</li> <li class="seamTextUnorderedListItem">May require 1 additional vaccine</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The neoantigen peptide vaccine will be personalized to your cancer based on your blood and biopsy results.</li> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy.</li> <li class="seamTextUnorderedListItem">The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Before you receive the vaccine, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the vaccine.</li> <li class="seamTextUnorderedListItem">Sargramostim is a type of immunotherapy that stimulates your body to produce more immune cells to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05269381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20529594?_ga=2.9537585.506318734.1653082699-1752475516.1651774270' target='_blank'>Mayo Clinic: Clinical Trial Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20884-sargramostim-gm-csf-injection' target='_blank'>Cleveland Clinic: Sargramostim</a> </li></ul>

106

NEAREST SITE: 2385 miles
Duke Cancer Institute
Durham,NC

VISITS: 1 visit every 3 weeks for 2-4 months

PHASE: I

NCT ID: NCT05076760

MEM-288 Vaccine for Advanced Triple Negative Breast Cancer

Phase I Study of MEM-288 Oncolytic Virus in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of MEM-288, an experimental vaccine.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has progressed after treatment with chemotherapy and at least 1 PD-1/PD-L1 inhibitor. Full eligibility criteria

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 vaccine, by injection, every 3 weeks, 2-6 sessions over 2-4 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires at least 1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEM-288 is a vaccine that contains an oncolytic virus, a type of virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">MEM-288 is injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05076760' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.memgenbio.com/' target='_blank'>Memgen Drug Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dukehealth.org/clinical-trials/directory/pro00109517' target='_blank'>Duke Health Clinical Trial Information Page: MEM-288</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/?utm_source=google&utm_medium=cpc&gclid=CjwKCAjwy_aUBhACEiwA2IHHQEa-vmAWsJZO8726oOg7bjIG8ru8smOjq4_rDRC9cRbLdE3XRu6cVRoCwCEQAvD_BwE' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/en-us/immunotherapy/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute: Oncolytic Viruses</a> </li></ul>

107

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 6 visits over 2 months

PHASE: I

NCT ID: NCT04270149

ESR1 Peptide Vaccine for Stage II-III, ER+ Breast Cancer That Tests Positive for HLA

A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer Scientific Title

Purpose

To study the safety and the effects on the immune system of receiving a vaccine along with two other immunotherapies.

Who is this for?

People with stage II or stage III estrogen receptor positive (ER+) breast cancer whose tumor was at least 5 cm and tested positive for HLA, and who are within two years of having completed treatment. Full eligibility criteria

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You will receive the following 6 times over 7 weeks: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ESR1 peptide vaccine, by injection</li> <li class="seamTextUnorderedListItem">Montanide, by injection</li> <li class="seamTextUnorderedListItem">GM-CSF, by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental vaccine used in this trial is an ESR1 peptide vaccine.</li> <li class="seamTextUnorderedListItem">Montanide and GM-CSF are immunotherapies researchers believe will make the ESR1 peptide vaccine more effective.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04270149' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.dukecancerinstitute.org/clinical-trial/pro00104868' target='_blank'>Duke Cancer Institute Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/montanide-isa-720' target='_blank'>NCI Drug Dictionary: Montanide</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gm-csf' target='_blank'>NCI Dictionary of Cancer Terms: GM-CSF</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3135' target='_blank'>ASCO Abstract: ESR1 Mutations Provide Novel Targets for Breast Cancer Immunotherapy</a> </li></ul>

108

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 1 visit every week

PHASE: II

NCT ID: NCT05325632

Dendritic Cell Vaccine With Neoadjuvant Therapy for HER2 Positive Breast Cancer

A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental immunotherapy, with targeted therapy and chemotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have not received surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, weekly for 6 weeks, then 3 times within 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 5 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 5 months</li> </ul> followed 2 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after HER2+ cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are types of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®) is a chemotherapy drug commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like hormone therapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancerorg: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancerorg: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancerorg: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancerorg: Paclitaxel (Abraxane®)</a> </li></ul>

109

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 1 visit every week for 1.5-3 months

PHASE: I

NCT ID: NCT05809752

Dendritic Cell Vaccine for Metastatic Triple Negative or HER2+ Breast Cancer With Leptomeningeal Disease

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer with leptomeningeal disease (LMD). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Procedure to place Ommaya reservoir</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by Ommaya reservoir, weekly for 1.5-3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that has spread to the leptomeninges is called leptomeningeal disease (LMD).</li> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF), the fluid or liquid surrounding your brain and spinal cord.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05809752' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancer.org: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are' target='_blank'>Cancer Research UK: Leptomeningeal Metastasis</a> </li></ul>

110

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05694364

PRGN-3007 CAR T Cell Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRGN-3007 CAR T-cells, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR-1 positive breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR T-cells</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR-T or CAR T cells are an experimental personalized immunotherapy made from your white blood cells. The white blood cells are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood cells are then infused into your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study trains the immune system to attack cancer cells that test positive for the protein ROR-1.</li> <li class="seamTextUnorderedListItem">Before you receive PRGN-3007 T-cells, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the immunotherapy.</li> <li class="seamTextUnorderedListItem">Leukapheresis is a procedure to collect your white blood cells to make your personalized CAR T-cell therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR-1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://precigen.com/pipeline/' target='_blank'>Precigen: PRGN-3007 Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapies/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-Cell Therapy</a> </li></ul>

111

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT05378464

T-Cell Therapy, Dendritic Cell Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic cell vaccines with pepinemab, an experimental targeted therapy, and trastuzumab (Herceptin®), a HER2-targeted therapy.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on trastuzumab (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> followed by (2 weeks after last vaccine): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for at least 2 months</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your T cells</li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer cells, and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, trastuzumab (Herceptin®), and booster doses of the dendritic cell vaccine every 3 weeks.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

112

NEAREST SITE: 2413 miles
Florida Cancer Specialists - Sarasota
Sarasota,FL

VISITS: 1 visit every 2 weeks

PHASE: I

NCT ID: NCT06150664

CTX-8371 Bispecific Antibody for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of CTX-8371, an experimental immunotherapy called a bispecific antibody.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CTX-8371, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CTX-8371 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">CTX-8371 is a bispecific antibody that targets PD-1 and PD-L1.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06150664' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.compasstherapeutics.com/pipeline/' target='_blank'>Compass Therapeutics: CTX-8371 Drug Information Page</a> </li></ul>

113

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization for 3-4 weeks

PHASE: I

NCT ID: NCT06253520

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental T cell therapy using a person's own modified white blood cells with an experimental vaccine.

Who is this for?

People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem">T cells, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer cells produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood cells (T cells) from a person, changing those cells so they will target the specific proteins (antigens) from the cancer cells, and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white cells work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood cells are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

114

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for up to 9 days; screening test every few months for 2 years

PHASE: II

NCT ID: NCT03412877

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of an immunotherapy that uses personalized T cells.

Who is this for?

People with metastatic (stage IV) breast cancer for which standard treatments have not worked. Full eligibility criteria

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You will be in the hospital and receive the following: Before hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells), 2-4 months before receiving treatment</li> </ul> Hospital stay for receiving treatment (2-3 weeks): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, once a day, for 2 days </li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara), by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Followed by Aldesleukin, by IV, once every 8 hours, for up to 4 days </li> <li class="seamTextUnorderedListItem">TCR-Transduced T-Cells, by IV</li> </ul> After hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic and antiviral, for at least 6 months</li> <li class="seamTextUnorderedListItem">Screening tests, every few months for the first year, every 6 months for the second year, then as determined</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer cells will be analyzed to learn about the genetic mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>

115

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for at least 1 week; follow-up visits for 2 years

PHASE: I-II

NCT ID: NCT02830724

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers Scientific Title

Purpose

To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. Full eligibility criteria

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You will receive the following: Hospital stay (at least 1-week): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> Post-hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

116

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for about 4 weeks

PHASE: II

NCT ID: NCT01174121

Individualized Immunotherapy for Metastatic Breast (and Other) Cancer

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab Scientific Title

Purpose

To study a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient.

Who is this for?

People with metastatic (stage IV) breast cancer and have a tumor that can be surgically removed. Full eligibility criteria

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All participants will undergo the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor sample used to grow the tumor infiltrating lymphocyte</li> <li class="seamTextUnorderedListItem">White blood cells-depleting preparative regimen</li> <li class="seamTextUnorderedListItem">Followed by tumor Infiltrating Lymphocytes, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor infiltrating lymphocytes (TILs) are the white blood cells that are found in tumors. </li> <li class="seamTextUnorderedListItem">The immune system has activated these cells to try to control the cancer's growth. </li> <li class="seamTextUnorderedListItem">This study is investigating a new type of immunotherapy in which researchers take TILs from tumors, grow the ones that are most effective in fighting the cancer in the laboratory, and then give the cells back to the patient. </li> <li class="seamTextUnorderedListItem">Previous studies using TIL in melanoma have shown effectiveness in shrinking the tumor. </li> <li class="seamTextUnorderedListItem">In this study, researchers will study the effectiveness of TIL in shrinking breast (and other) tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01174121' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.gov/ct2/show/NCT01174121' target='_blank'>ClinicalTrials.gov: Trial Information</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.esmo.org/Conferences/Past-Conferences/ESMO-2014-Congress/News-Articles/The-Promise-of-Tumour-Infiltrating-Lymphocytes-for-Cancer-Treatment-and-as-Prognostic-Predictive-Indicators' target='_blank'>ESMO: Tumor Infiltrating Lymphocytes in Melanoma</a> </li></ul>

117

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization

PHASE: I

NCT ID: NCT05035407

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers Scientific Title

Purpose

To study the safety and best dose of gene therapy with KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?

People with KK-LC-1 positive (KK-LC-1+) metastatic (stage IV) breast cancer with a HLA mutation that has progressed on standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, daily, 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, daily, 5 days</li> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by injection, 1 session</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily, 4 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for 3-4 weeks</li> <li class="seamTextUnorderedListItem">May require follow-up visits every 3-6 months for up to 5 years</li> <li class="seamTextUnorderedListItem">May require questionnaires for up to 15 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 T cell receptor (TCR) T cells is an experimental type of immunotherapy that trains the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune cells called T cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

118

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Every 2 weeks for 1 year

PHASE: I-II

NCT ID: NCT02484404

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of giving MEDI4736 and Lynparza together.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer for whom no currently available treatment exists. You must not have received more than three prior therapies for metastatic disease. Full eligibility criteria

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Participants will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (MEDI4736) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. </li> <li class="seamTextUnorderedListItem">Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02484404' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=740856' target='_blank'>NCI Drug Dictonary: MEDI4736</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=560191' target='_blank'>NCI Drug Dictonary: Olaparib</a> </li></ul>

119

NEAREST SITE: 2433 miles
Sibley Memorial Hospital
Washington,DC

VISITS: 3 visits for the first week, then every 3 weeks for 3 months, then every 6 weeks, ongoing

PHASE: II

NCT ID: NCT04837209

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving radiation therapy with a PARP inhibitor and a PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a BRCA 1/2 mutation (inherited or tumor). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, 3 times, during the first week of treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple-negative as well as ER Low breast cancer. </li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®)is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Researchers believe that radiation therapy may also boost the immune system, which will help the immune system go after and kill cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>

120

NEAREST SITE: 2434 miles
Georgetown Lombardi Comprehensive Cancer Center
Washington,DC

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05256745

Azeliragon to Decrease Cardiotoxicity and Cognitive Decline During Chemotherapy in Women with Stage I-III Breast Cancer

RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer Scientific Title

Purpose

To study the ability of azeliragon to decrease cardiotoxicity (heart damage caused by cancer treatment) and cognitive decline side effects of chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III breast cancer who have not yet received treatment and are planning to receive chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1: Azeliragon with AC/T Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), 5.5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 5.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> </ul> Group 2: Azeliragon with CT Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 3-4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> </ul> Group 3: Azeliragon with TCHP Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), 4 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), 4 months</li> </ul> Group 4: Azeliragon with Combination of Chemotherapy and Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon, by mouth, daily</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), 4 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), 3-4 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 5.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), depending on type of cancer</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 months, depending on type of cancer</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azeliragon is an experimental drug that may reduce cardiotoxicity and cognitive decline side effects of chemotherapy. It is also being studied for treating Alzheimer's and glioblastoma, a type of brain cancer.</li> <li class="seamTextUnorderedListItem">Some breast cancer treatments can cause or increase the risk of heart problems, which is called cardiotoxicity. </li> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), paclitaxel (Taxol®), docetaxel (Taxotere®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and Pertuzumab (Perjeta®) are anti-HER2 targeted therapies routinely used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05256745' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diseases/16858-chemotherapy--the-heart-cardiotoxicity#:~:text=Cardiotoxicity%20refers%20to%20any%20heart,radiation%20therapy%20to%20the%20chest.' target='_blank'>Cleveland Clinic: Cardiotoxicity Cancer Treatment and the Heart</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/fda-grants-orphan-drug-designation-to-azeliragon-for-gbm' target='_blank'>OncLive: Azeliragon for Brain Cancer and Cancer Treatment-Related Complications</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

121

NEAREST SITE: 2436 miles
Brain Tumor Institute, Children's National Medical Center
Washington,DC

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT03652545

TAA-T T-Cell Immunotherapy for Brain Metastasis

Phase I REsearch on Multi-antigen T Cell Infusion Against Neuro-oncologic Disease Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of TAA-T T-cell therapy, an experimental immunotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) and have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy, by IV, 1-9 sessions every 4-6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) T-cell therapy is an experimental immunotherapy.</li> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy are tumor-specific immune cells generated from your blood cells.</li> <li class="seamTextUnorderedListItem">TAA-T T-cell therapy may initiate an immune response against brain tumors and prevent tumor progression.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03652545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

122

NEAREST SITE: 2517 miles
University of Pennsylvania
Philadelphia,PA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05623488

CAR T Cell Therapy for Advanced Triple Negative, Mesothelin Expressing Breast Cancer

Phase 1, Adaptive-design Trial of Human Chimeric Antigen Receptor Modified T Cells in Patients With Mesothelin Expressing Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of huCART-meso cells, an experimental CAR T cell therapy.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses mesothelin. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mesothelin expression testing on your tumor</li> <li class="seamTextUnorderedListItem">huCART-meso cells</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">huCART-meso is an experimental immunotherapy called CAR T cell therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein.</li> <li class="seamTextUnorderedListItem">The CAR T cells are then infused back into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">The CAR T cell therapy being used in this study trains the immune system to attack mesothelin expressing cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05623488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

123

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT06110793

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

124

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Please contact research site

PHASE: I

NCT ID: NCT06246968

Pembrolizumab and Cryoablation for Advanced Triple Negative Breast Cancer

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer? Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor with cryoablation, an experimental alternative to surgery.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received 1-2 lines of therapy and are planning to receive pembrolizumab (Keytruda®). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Cryoablation</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Cryoablation is a procedure in which an extremely cold liquid or device is used to freeze and destroy cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06246968' target='_blank'>ClinicalTrials.gov</a> </li></ul>

125

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 8 visits over 2 months

PHASE: II

NCT ID: NCT04683679

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses Scientific Title

Purpose

To study the safety and anti-cancer activity of using radiation therapy and the immunotherapy pembrolizumab (Keytruda®) with or without the PARP inhibitor olaparib (Lynparza®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a PARP inhibitor or more than two systemic therapies for advanced disease. To enroll, you must not have a BRCA 1/2 mutation (inherited or tumor). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor or PD-1 inhibitor. It helps the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple-negative breast cancer, but its use in this trial, however, is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It works by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation. Its use in this trial, however, is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04683679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/does-immunotherapy-treat-breast-cancer.h00-159385101.html' target='_blank'>MD Anderson Cancer Center: Does Immunotherapy Treat Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-keytruda-for-pd-l1-pos-tnbc' target='_blank'>Breastcancer.org: FDA Approves Immunotherapy Keytruda for PD-L1-Positive Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li></ul>

126

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 2 visits within 3 months

PHASE: II

NCT ID: NCT05203445

Neoadjuvant Targeted Therapy and Immunotherapy for Stage I-III HER2- Breast Cancer

Phase II of Neoadjuvant Olaparib in Combination With Pembrolizumab in Patients With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer and Germline Mutations in DNA Damage Repair Genes Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor with pembrolizumab (Keytruda®) immunotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III HER2 negative (HER2-) breast cancer who have an inherited BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutation and have not yet received surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice within 3 months</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 3 months</li> </ul> possibly followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">If your tumor does not grow, you will also receive chemotherapy.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2, RAD51C, RAD51D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05203445' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

127

NEAREST SITE: 2548 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05483491

KK-LC-1 TCR T Cell Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), KK-LC-1 positive (KK-LC-1+) breast cancer with a HLA mutation who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by IV, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily for 1-2 days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells are an experimental immunotherapy that train the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an infusion.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">KK-LC-1 is an abnormal protein that is expressed by certain types of cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: KK-LC-1, HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05483491' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/treatments/immunotherapy/cellular-immunotherapy/tcr-therapy/' target='_blank'>Moffitt Cancer Center: T-Cell Receptor (TCR) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

128

NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: 5 visits per month, ongoing

PHASE: II

NCT ID: NCT04445844

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of combining the experimental checkpoint inhibitor MGA012 with the oncolytic virus pelareorep.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received one to three prior therapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pelareorep, by IV, 2 days a week, every other week, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">Pelareorep is an oncolytic virus--a virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04445844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>Macrogenics Drug Information Page: Retifanlimab (MGA012)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pelareorep' target='_blank'>Wikipedia: Pelareorep</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2020/09/14/first-patient-dosed-irene-clinical-trial-testing-immunotherapy-oncolytic-virus-combo-for-tnbc/' target='_blank'>Breast Cancer News: First Patient Dosed in IRENE Trial Testing Immunotherapy-Oncolytic Virus Combo</a> </li><li class='seamTextUnorderedListItem'><a href='https://graspcancer.org/wp-content/uploads/2021/12/Group6E_2.pdf' target='_blank'>GRASP: IRENE Study research poster</a> </li></ul>

129

NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: Please contact research site

PHASE: II

NCT ID: NCT03428802

Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability Scientific Title

Purpose

To study the effects (good and bad) of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been tested for and found to have a BRCA 1 or BRCA 2 tumor mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </li> <li class="seamTextUnorderedListItem">Keytruda® is currently approved to treat certain types of cancers.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>

130

NEAREST SITE: 2563 miles
Hackensack University Medical Center
Hackensack,NJ

VISITS: 3-4 visits per month, for 6 months

PHASE: I-II

NCT ID: NCT05144698

RAPA-201 Immunotherapy for Advanced Triple Negative Breast Cancer

Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors Scientific Title

Purpose

To determine the safety of RAPA-201 T-cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumor has progressed on treatment with an anti-PD-L1 immunotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (an apheresis procedure) to be used for the personalized RAPA-201 cell therapy</li> <li class="seamTextUnorderedListItem">Standard-of-care chemotherapy, by IV, once a week for 3 out of every 4 weeks</li> <li class="seamTextUnorderedListItem">RAPA-201, by IV, once a month for 5 months </li> </ul> A hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your white blood cells are modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">The chemotherapy used in this study is carboplatin and paclitaxel.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05144698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>

131

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center
New York,NY

VISITS: At least 6 visits, may require hospitalization

PHASE: I

NCT ID: NCT04150042

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation

SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stem cells with melphalan chemotherapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) BRCA1, BRCA2, or PALB2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to collect stem cells</li> </ul> followed by 2 rounds of: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Melphalan, by IV</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), by IV</li> <li class="seamTextUnorderedListItem">Vitamin B12b, by IV</li> <li class="seamTextUnorderedListItem">Vitamin C, by IV</li> <li class="seamTextUnorderedListItem">Ethanol, by IV</li> </ul> followed 2 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stem cells, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your stem cells will be collected from your body and modified in a lab so they can identify and attack cancer cells. These modified stem cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">Apheresis is a procedure to collect your stem cells. </li> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor is a drug that will help prepare your body and stem cells for apheresis.</li> <li class="seamTextUnorderedListItem">Melphalan is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), vitamin B12b, vitamin C, and ethanol will be given to improve the effectiveness of the stem cell infusion.</li> <li class="seamTextUnorderedListItem">You will receive two rounds of melphalan (Alkeran®) chemotherapy and stem cell infusion approximately 6 weeks apart.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04150042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sharontrial.com/' target='_blank'>General Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/research-clinical-trials/study/117/a-study-of-melphalan-bcnu-vitamin-b12b-vitamin-c-and-stem-cell-infusion-in-people-with-advanced-pancreatic-cancer-and-brca-mutations' target='_blank'>Facing Our Risk of Cancer Empowered: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/autologous-stem-cell-transplant/pyc-20384859' target='_blank'>Mayo Clinic: Autologous Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/process.html' target='_blank'>American Cancer Society: Getting a Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/melphalan-intravenous-route/side-effects/drg-20071590?p=1#:~:text=Melphalan%20injection%20is%20used%20to,alkylating%20agents%20(cancer%20medicines).' target='_blank'>Mayo Clinic: Melphalan</a> </li></ul>

132

NEAREST SITE: 2569 miles
Icahn School of Medicine at Mount Sinai
New York,NY

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03789097

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma Scientific Title

Purpose

To test the safety and effects (good and bad) of an experimental immunotherapy injected into metastases when combined with radiation and pembrolizumab (Keytruda®).

Who is this for?

People with metastatic (stage IV) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Flt3L(CDX-301), by injection</li> <li class="seamTextUnorderedListItem">Radiation, 2 small treatments, on day 1 and day 2</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol), by injection </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapies injected into the metastases are flt3L and poly-ICLC. </li> <li class="seamTextUnorderedListItem">Flt3L is an immune cell growth factor. It gets the body to make more immune cells. </li> <li class="seamTextUnorderedListItem">Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. </li> <li class="seamTextUnorderedListItem">Radiation therapy will be targeted at the same metastases as these immunotherapies.</li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor that is given intravenously (IV). It stimulates the body's immune system to go after cancer cells. It is approved to treat more than 10 types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03789097' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celldex.com/pipeline/cdx-301.php' target='_blank'>Drug company information page: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/poly-iclc' target='_blank'>NCI Drug Dictionary: poly ICLC</a> </li></ul>