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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.

Use the search box and filters to find a trial that’s right for you.

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(Last updated: March 26, 2025)

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AKT

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ROS1

TP53

Click here to view online studies and trials that do not require site visits

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. You must have received surgery less than 3 months ago. 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</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
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 a combination of 2 experimental immunotherapies, adagloxad simolenin (OBI-822) and OBI-821.

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 treatment less than 3 months ago. 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
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
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

NCT ID: NCT05107674

NX-1607 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of NX-1607, an experimental CBL-B 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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NX-1607, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NX-1607 is an experimental immunotherapy called a CBL-B inhibitor that stimulates 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/NCT05107674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nurixtx.com/pipeline/' target='_blank'>Nurix Therapeutics: NX-1607 Drug Information Page</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
Ucsf /Id# 257705
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06084481

ABBV-400 ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of ABBV-400, an experimental antibody drug conjugate (ADC).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-400, by IV</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-400 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">ABBV-400's antibody targets cMet, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06084481' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/science/pipeline.html' target='_blank'>AbbVie: ABBV-400 Drug Information Page</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></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 Medical Center-Mission Bay/Benioff Children's Hospital
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03990896

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) BRCA1/2 Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Scientific Title

Purpose

To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) BRCA 1 or BRCA 2 mutation.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a BRCA 1 or a BRCA 2 tumor (not inherited) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA 1 (tumor), BRCA 2 (tumor)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (Data collection only)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06099769

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or ER Low, Androgen Receptor Positive Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of enzalutamide (Xtandi®), an experimental hormone therapy, alone or with mifepristone, an experimental hormone therapy, compared to standard of care chemotherapy.

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 ER low, androgen receptor positive (AR+) breast cancer who have received 0-1 lines of chemotherapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> Group 3: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is an anti-androgen hormone therapy approved for people with prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Mifepristone is an anti-progesterone hormone therapy. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), capecitabine (Xeloda®), and eribulin (Halaven®) are standard of care chemotherapy medications used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">If you are in group 3, you may be able to switch to group 2 if your cancer progresses.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06099769' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>Medline Plus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 3 miles
Curebase
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT04510129

Collecting Tumor Samples to Develop a Test to Predict Response to Treatment

Predicting Immunotherapy Efficacy From Analysis of Pre-treatment Tumor Biopsies Scientific Title

Purpose

To collect tumor samples that will be used to develop OncoPrism™, a test that helps providers predict response to immunotherapy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who have received or are planning to receive treatment with a PD-1/PD-L1 inhibitor. You must have received a biopsy before beginning treatment with a PD-1/PD-L1 inhibitor. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OncoPrism™ is a test that helps providers predict response to immunotherapy.</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/NCT04510129' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cofactorgenomics.com/technology/' target='_blank'>Cofactor Genomics: OncoPrism™ Test</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: 1 visit every week (2 weeks on, 1 week off), ongoing

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan for HER2 Negative Breast Cancer Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <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. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan 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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04647916' target='_blank'>ClinicalTrials.gov</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.targetedonc.com/view/sacituzumab-govitecan-shows-pfs-benefit-for-patients-with-mtnbc-and-brain-metastases' target='_blank'>Targeted Oncology: Sacituzumab Govitecan Shows PFS Benefit for Patients With mTNBC and Brain Metastases</a> </li></ul>

NEAREST SITE: 23 miles
Bass Medical Group ( Site 0089)
Walnut Creek,CA

VISITS: At least 1 visit every 1.5 months for 6 months

PHASE: III

NCT ID: NCT06393374

Sacituzumab Tirumotecan ADC with Immunotherapy for Stage I-III Triple Negative Breast Cancer

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery (... Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of adjuvant (after surgery) sacituzumab tirumotecan, an experimental antibody drug conjugate (ADC), with pembrolizumab (Keytruda®) PD-1 inhibitor compared to standard of care pembrolizumab (Keytruda®) with or without chemotherapy.

Who is this for?

People with stage I, stage II, and stage III triple negative (ER-, PR-, HER2-) breast cancer who received neoadjuvant (before surgery) pembrolizumab (Keytruda®) with chemotherapy and surgery. You must have cancer cells remaining (non-pathologic complete response) after surgery less than 3 months ago. 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®), by IV, every 1.5 months for 6 months</li> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (sac-TMT), by IV, every 2 weeks for 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan 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 tirumotecan targets TROP2 proteins. It delivers the chemotherapy belotecan.</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.</li> <li class="seamTextUnorderedListItem">Non-pathologic complete response is the presence of cancer cells after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06393374' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Sacituzumab Tirumotecan Drug Information Page</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 Cancer Institute
Palo Alto,CA

VISITS: 1 visit per month

PHASE: II

NCT ID: NCT05305365

QBS72S Chemotherapy for Metastatic Triple Negative Breast Cancer with Brain or Leptomeningeal Metastasis

A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of QBS72S, an experimental chemotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases) or leptomeningeal metastasis visible on an MRI who have received chemotherapy. If you have brain metastasis, you must have at least 1 lesion that has not received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S, by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">QBS72S is an experimental chemotherapy that may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Leptomeningeal metastasis (LM) is when cancer has spread to the leptomeninges, also called leptomeningeal carcinomatosis, leptomeningeal disease (LMD), leptomeningeal cancer, neoplastic meningitis, meningeal metastasis, and meningeal carcinomatosis, among other names.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305365' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quadrigabiosciences.com/science/' target='_blank'>Quadriga Biosciences: QBS72S Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04300556

Experimental Antibody-Drug Conjugate MORAb-202 for Women with Metastatic Triple Negative Breast Cancer that Tests Positive for FRA

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRÎ±)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental antibody-drug conjugate MORAb-202.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have already received a platinum-based chemotherapy and whose tumor tests positive for FRA. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MORAb-202, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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. 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">MORAb-202 is an experimental ADC. </li> <li class="seamTextUnorderedListItem">Its antibody targets FAR, a protein, and it delivers an anti-cancer drug called eribulin mesylate.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling women with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04300556' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.5544' target='_blank'>Journal Article Abstract: MORAb-202</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University Medical Center
Stanford,CA

VISITS: At least 1 visit every 1-1.5 months

PHASE: I

NCT ID: NCT06562192

Radioactive Drug for Advanced HR+, HER2- or Triple Negative Breast Cancer

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of [177Lu]Lu-NNS309, an experimental radioactive drug.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or triple negative (ER-, PR-, HER2-) breast cancer who have received at least 2 lines of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT or PET/MRI scan with 68Ga-Ga-NNS309, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-Lu-NNS309, by IV, every 1-1.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NNS309 is an experimental radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to 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> <li class="seamTextUnorderedListItem">68Ga-Ga-NNS309 is a tracer that can look for and attach to 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/NCT06562192' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/nct06562192' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy#:~:text=Once%20a%20radiopharmaceutical%20has%20stuck,irreparably%20damaged%2C%20that%20cell%20dies' target='_blank'>National Cancer Institute: Radiopharmaceuticals</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
Stanford,CA

VISITS: 2 visits within 6 months

PHASE: II

NCT ID: NCT04768426

ctDNA Monitoring During Chemotherapy for Stage I-III Triple Negative Breast Cancer

Phase II Trial of Circulating Tumor DNA Monitoring During Adjuvant Capecitabine in Patients With Triple-negative Breast Cancer and Residual Disease Following Standard Neoadjuvant Chemotherapy Scientific Title

Purpose

To use circulating tumor DNA (ctDNA) to identify who will or will not experience benefit from adjuvant (after surgery) 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 who have residual disease after neoadjuvant (before surgery) chemotherapy and surgery. You must be planning to receive capecitabine (Xeloda®) after surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> <li class="seamTextUnorderedListItem">Blood test, 2 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">ctDNA tests are also called liquid biopsies.</li> <li class="seamTextUnorderedListItem">In this study, changes in ctDNA in the blood will be monitored over time during capecitabine (Xeloda®) treatment and related to genetic mutations in tumors. </li> <li class="seamTextUnorderedListItem">Results from this study may provide information for future clinical trials in which patients receive a different treatment than capecitabine (Xeloda®) to reduce their risk of breast cancer coming back (recurrence).</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells 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/NCT04768426' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05123482

AZD8205 for Advanced Triple Negative BreastCancer

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies Scientific Title

Purpose

To determine the safety, side effects, dose, and anti-cancer activity of AZD8205, and antibody-drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must not have received more than one line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8205, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05123482' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 53 miles
Providence Medical Group Santa Rosa - Cancer Center
Santa Rosa,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05891171

AB598 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AB598, an experimental CD39 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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB598, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AB598 is an experimental immunotherapy called a CD39 inhibitor. Blocking CD39 may help the immune system to find and attack 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/NCT05891171' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://arcusbio.com/our-science/discovery-candidates/' target='_blank'>Arcus Biosciences: AB598 Drug Information Page</a> </li></ul>

NEAREST SITE: 53 miles
Research Site
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06103864

Dato-DXd ADC With or Without Durvalumab Immunotherapy for Advanced Triple Negative, PD-L1 Positive Breast Cancer

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast (TROPION-Breast05) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate (ADC), with or without durvalumab immunotherapy compared to standard of care chemotherapy with pembrolizumab 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 not yet received treatment for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Group 3: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental 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">Datopotamab deruxtecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are a type of immunotherapy called PD-1 inhibitors, which are 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, standard of care chemotherapy drugs include carboplatin (Paraplatin®), paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), and/or gemcitabine (Gemzar®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06103864' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D7630C00001/' target='_blank'>AstraZeneca: Trial Information Page</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: Datopotamab Deruxtecan (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 (Imfinzi®)</a> </li></ul>

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

VISITS: About 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05684965

XTX301 Immunotherapy for Advanced Triple Negative Breast Cancer

A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX301 in Patients with Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of XTX301, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than 4 lines of therapy for advanced disease. You must not have liver metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XTX301</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XTX301 is an experimental immunotherapy called interleukin-12 (IL-12).</li> <li class="seamTextUnorderedListItem">IL-12 activates immune cells to 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/NCT05684965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://xiliotx.com/pipeline/xtx301' target='_blank'>Xilio: XTX301 Drug Information Page</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: 6 visits within 2 months

PHASE: I

NCT ID: NCT05967533

Fermented Wheat Germ with Immunotherapy for Advanced Triple Negative Breast Cancer

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of fermented wheat germ nutritional supplement.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive dostarlimab (Jemperli®) or pembrolizumab (Keytruda®) immune checkpoint inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fermented wheat germ, by mouth, daily for 2 months</li> <li class="seamTextUnorderedListItem">Blood tests, 6 times</li> <li class="seamTextUnorderedListItem">Stool samples, 4 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fermented wheat germ is a nutritional supplement that may boost the immune response to cancer.</li> <li class="seamTextUnorderedListItem">Immune checkpoint inhibitors are a type of immunotherapy that may help 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">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/NCT05967533' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/integrative-medicine/herbs/wheat-germ-extract' target='_blank'>Memorial Sloan Kettering Cancer Center: Fermented Wheat Germ</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immune Checkpoint Inhibitors</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05208762

SGN-PDL1V Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of SGN-PDL1V, an experimental antibody drug conjugate (ADC).

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">SGN-PDL1V, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V is an experimental 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 PD-1/PD-L1, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called vedotin.</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/NCT05208762' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrials.seagen.com/study/?pid=SGNPDL1V-001' target='_blank'>Seagen Trial Information Page: SGN-PDL1V</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://investor.seagen.com/press-releases/news-details/2021/Seagen-to-Highlight-Two-Novel-Antibody-Drug-Conjugates-ADCs-at-the-SITC-36th-Annual-Meeting/default.aspx' target='_blank'>Seagen Press Release: SGN-PDL1V</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: 250 miles
Research Site
Bakersfield,CA

VISITS: 1 visit every 1-3 weeks for 1 year

PHASE: III

NCT ID: NCT06112379

Dato-DXd ADC and Immunotherapy Before Surgery for Stage II-III Triple Negative or HR Low, HER2- Breast Cancer

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Tr... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) datopotamab deruxtecan (Dato-DXd), an experimental antibody drug conjugate, and durvalumab (Imfinzi®) PD-1 inhibitor with or without chemotherapy compared to standard of care.

Who is this for?

People with newly diagnosed stage II or stage III triple negative (ER-, PR-, HER2-) or hormone receptor low (ER low and/or PR low), HER2 negative (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: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks, for 6 months before surgery</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, for 6 months before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, before surgery</li> <li class="seamTextUnorderedListItem">Chemotherapy, before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) combines an antibody that targets cancer cells with a therapy that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Because it only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Dato-DXd's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are types of immunotherapy called PD-L1 inhibitors, which are 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">Olaparib (Lynparza®) is a targeted therapy called a PARP inhibitor, which work by blocking the action of an enzyme that helps repair DNA. It will be given to people with residual disease and BRCA positive (BRCA+) tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html#oncology' target='_blank'>AstraZeneca: Datopotamab Deruxtecan (Dato-DXd) Drug Information Page</a> </li></ul>

NEAREST SITE: 336 miles
University of California, Los Angeles (UCLA)
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04115306

Targeted Therapy PMD-026 for Metastatic Triple Negative Breast Cancer

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To determine the best dose, safety, and effects of the drug PMD-026.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Ribosomal_s6_kinase' target='_blank'>Wikipedia: RSK</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
UCLA
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06036121

ADRX-0706 Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1a/b Study of ADRX-0706 in Subjects with Select Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of ADRX-0706, an experimental antibody drug conjugate.

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. You must have received at least 1 line of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADRX-0706</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADRX-0706 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">ADRX-0706's antibody targets nectin-4, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06036121' 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></ul>

NEAREST SITE: 339 miles
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06449222

BNT327 with Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of BNT327, an experimental anti-cancer therapy, with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR, HER2-) breast cancer who have received 0-1 lines of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BNT327 is an experimental anti-cancer therapy.</li> <li class="seamTextUnorderedListItem">You will receive at least one chemotherapy drug: either a taxol or combination of antimetabolite and alkylating agent.</li> <li class="seamTextUnorderedListItem">Taxol chemotherapy drugs include paclitaxel (Taxol®) and docetaxel (Taxotere®).</li> <li class="seamTextUnorderedListItem">Antimetabolite chemotherapy drugs include fluorouracil (5-FU) and methotrexate.</li> <li class="seamTextUnorderedListItem">Alkylating agent chemotherapy drugs include cyclophosphamide (Cytoxan®) and carboplatin (Paraplatin®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06449222' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 340 miles
NextGen Oncology
Beverly Hills,CA

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT06249048

STX-001 mRNA Injection with Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of STX-001, an experimental mRNA drug, 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 received chemotherapy and pembrolizumab (Keytruda®) or dostarlimab (Jemperli®) for advanced disease. You must have at least 1 tumor that has not received radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-001, by injection into tumor</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by injection, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-001 is an experimental mRNA drug. It contains genetic instructions that allow your body to produce interleukin-12 (IL-12). IL-12 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/NCT06249048' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2022/mrna-vaccines-to-treat-cancer' target='_blank'>National Cancer Institute: Can mRNA Vaccines Help Treat Cancer?</a> </li></ul>

NEAREST SITE: 348 miles
University of Southern California
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05902988

VLS-1488 Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of VLS-1488, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 2 lines of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VLS-1488, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VLS-1488 is an experimental targeted therapy called a KIF18A inhibitor. KIF18A inhibitors may slow or stop cancer cells from growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05902988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.volastratx.com/pipeline/' target='_blank'>Volastra Therapeutics: VLS-1488 Drug Information Page</a> </li></ul>

NEAREST SITE: 348 miles
USC/Norris Comprehensive Cancer 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: 1 visit every week

PHASE: I

NCT ID: NCT05783622

JANX008 Targeted Therapy for Advanced Triple Negative Breast Cancer

An Open-Label, Multicenter, Phase 1/1b Study of JANX008 in Subjects with Advanced or Metastatic Solid Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of JANX008, an experimental EGFR 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">JANX008, by IV, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JANX008 is an experimental targeted therapy called an EGFR inhibitor. Blocking EGFR may slow or stop cancer cells from growing.</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/NCT05783622' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.januxrx.com/egfr-tractr-janx008/' target='_blank'>Janux Therapeutics: JANX008 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.urologytimes.com/view/immunotherapies-show-safety-and-efficacy-in-mcrpc-renal-cell-carcinoma' target='_blank'>Urology Times: JANX008 for Advanced Cancers</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 1 visit every 2-3 months

PHASE: I-II

NCT ID: NCT06399757

APL-5125 Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of APL-5125, an experimental kinase 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">APL-5125, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">APL-5125 is a type of targeted therapy called a kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</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/NCT06399757' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.apollotx.com/pipeline/' target='_blank'>Apollo Therapeutics: APL-5125 Drug Information Page</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05325866

Bemarituzumab Targeted Therapy for Advanced Triple Negative Breast Cancer that Expresses FGFR2b

A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of bemarituzumab, an experimental FGFR2b inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses FGFR2b who have received at least 1 line of therapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bemarituzumab (AMG 552), by IV</li> </ul> Please contact research site
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bemarituzumab (AMG 552) is an experimental targeted therapy called a FGFR2b inhibitor. Targeting FGFR2b may slow or stop cancer cell growth.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. It is enrolling people with other types of cancer based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: FGFR2b, FGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325866' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amgenpipeline.com/' target='_blank'>Amgen Drug Information Page: Bemarituzumab</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: 353 miles
City of Hope National Medical Center /ID# 265620
Duarte,CA

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: 353 miles
Exelixis Clinical Site #4
Duarte,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT06545331

XB010 ADC for Advanced HR+ or Triple Negative Breast Cancer

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of XB010, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) or 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">XB010, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XB010 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">XB0101's antibody targets 5T4, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called MMAE.</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/NCT06545331' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exelixis.com/clinical-trials-pipeline/' target='_blank'>Exelixis: XB010 Drug Information Page</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></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 2 visits within 1.5 months

PHASE: NA

NCT ID: NCT03463954

Novilase® Laser Ablation Before Surgery for Women with Stage I-II BRCA Negative Breast Cancer

Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of Novilase® laser ablation to standard of care lumpectomy for small tumors.

Who is this for?

Women with some stage I or stage II breast cancer who have not yet received surgery. You must not have BRCA positive, lobular, or triple negative breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Novilase® laser ablation</li> </ul> followed 1-1.5 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Novilase® laser ablation system kills tumor cells by heating the tissue with a laser.</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/NCT03463954' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://novilase.com/' target='_blank'>Novian Health: Novilase®</a> </li></ul>

NEAREST SITE: 366 miles
Cancer and Blood Specialty Clinic
Los Alamitos,CA

VISITS: 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT05933265

LP-184 Chemotherapy for Advanced Triple Negative Breast Cancer or Breast Cancer with DNA Damage Mutations

A Phase 1/2 Dose Escalation and Cohort Expansion Study of LP-184 in Patients with Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of LP-184, an experimental chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with a DNA damage 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">LP-184, by IV, weekly, 2 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LP-184 is an experimental chemotherapy drug causing tumor cell death through DNA damage.</li> <li class="seamTextUnorderedListItem">DNA damage mutations may include BRCA1, BRCA2, PALB2, ATM, CHEK2, and others.</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/NCT05933265' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lanternpharma.com/clinical-trials' target='_blank'>Lantern Pharma: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lanternpharma.com/compassionate-use#ExpandedAccessTNBC' target='_blank'>Lantern Pharma: LP-184 Compassionate Use for Triple Negative Breast Cancer</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: 375 miles
Knowledge Research Center
Orange,CA

VISITS: 2 times within 6 months, then 3 times within 2 years

PHASE: NA

NCT ID: NCT04638751

Stool and Blood Sample Bank to Develop New Treatments for Triple Negative Breast Cancer

ARGONAUT: Development and Analysis of a Blood and Stool Sample Bank for Cancer Patients, Enabling the Systematic Study of the Effect of Gut Microbiomes on Response to Treatment Scientific Title

Purpose

To collect stool and blood samples to study gut microbiomes, study cancer biomarkers, and develop new treatments.

Who is this for?

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

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool and blood samples, 2 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool samples will be used to study your gut microbiome, which are the microorganisms that live in your digestive system. Drugs that target your microbiome may be helpful to treat cancer.</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/NCT04638751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/nutrition/gut-microbiome-and-health' target='_blank'>Healthline: Gut Microbiome</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aiche.org/resources/publications/cep/2020/october/developing-precision-microbiome-medicines' target='_blank'>American Institute of Chemical Engineers: Developing Precision Microbiome Medicines</a> </li></ul>

NEAREST SITE: 496 miles
Oregon Oncology Specialists
Salem,OR

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06230185

Detecting ctDNA After Chemotherapy for Women with Stage I-III Triple Negative Breast Cancer

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I) Scientific Title

Purpose

To study the relationship between circulating tumor DNA (ctDNA) and pathological complete response (no signs of cancer) after neoadjuvant (before surgery) chemotherapy.

Who is this for?

Women with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who are planning to receive neoadjuvant (before surgery) chemotherapy. Full eligibility criteria

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You will provide the following for ctDNA and genomic testing: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples, before and during treatment</li> <li class="seamTextUnorderedListItem">Tumor samples, during surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">ctDNA can be detected in blood with a <q>liquid biopsy</q>.</li> <li class="seamTextUnorderedListItem">The absence of ctDNA is associated with a pathological complete response (no signs of cancer).</li> <li class="seamTextUnorderedListItem">Detection of ctDNA is associated with cancer recurrence (cancer coming back).</li> <li class="seamTextUnorderedListItem">Pathological complete response (pCR) means there are no signs of cancer in tissue samples removed during surgery after neoadjuvant (before surgery) treatment.</li> <li class="seamTextUnorderedListItem">Information from this study will be used to improve the detection of ctDNA for future patients.</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/NCT06230185' target='_blank'>ClinicalTrials.gov</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: 533 miles
Site 9280
Portland,OR

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05565417

IMT-009 Targeted Therapy for Advanced Triple Negative Breast Cancer with a CD161 or CLEC2D Mutation

A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMT-009, an experimental CD161 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (HR+) breast cancer with a CD161 or CLEC2D 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">IMT-009, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMT-009 is an experimental targeted therapy called a CD161 inhibitor. Blocking CD161 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: CD161, CLEC2D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05565417' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20220922/fda-clears-ind-application-for-cancer-therapeutic-imt009' target='_blank'>Healio: IMT-009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/immunitas-therapeutics-receives-fda-clearance-of-ind-application-for-imt-009-in-solid-tumors-and-hematological-malignancies-301628999.html' target='_blank'>Immunitas Therapeutics Press Release: IMT-009</a> </li></ul>

NEAREST SITE: 533 miles
Oregon Health and Science University
Portland,OR

VISITS: 1 visit

PHASE: I

NCT ID: NCT06273852

PBA-0405 Targeted Therapy for Stage I-IV Triple Negative Breast Cancer

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (PB004) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PBA-0405, an experimental ROR1 inhibitor.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who are planning to receive surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0405, by injection into tumor with CIVO device, 1-2 days before surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0405 is an experimental targeted therapy called a ROR1 inhibitor. Blocking ROR1 may slow or stop cancer cells from growing. PBA-0405 may also help the immune system attack and kill tumor cells.</li> <li class="seamTextUnorderedListItem">The CIVO device helps the doctor inject the drug into a tumor or lymph node.</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/NCT06273852' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://presagebio.com/civo-platform/' target='_blank'>Presage Biosciences: CIVO Device</a> </li><li class='seamTextUnorderedListItem'><a href='https://purebiologics.com/project/pb004-purebike/' target='_blank'>Pure Biologics: PBA-0405 Drug Information Page</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05768932

BAL0891 Targeted Therapy Alone or With Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of BAL0891, an experimental TTK/PLK inhibitor, alone or with chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or ER low, HER2- or HER2 low) breast cancer who have received at least 1 line of therapy for advanced disease. You must not have received more than 4 lines of chemotherapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAL0891 is an experimental targeted therapy called a TTK/PLK inhibitor. Blocking TTK/PLK may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05768932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.sillajen.com/eng/sub/pipeline_bal0891.html' target='_blank'>SillaJen: BAL0891 Drug Information Page</a> </li></ul>

NEAREST SITE: 535 miles
Providence St. Vincent Medical Center
Portland,OR

VISITS: 1 visit every 3 weeks for 4-5 months

PHASE: II

NCT ID: NCT06353997

INBRX-106 Immunotherapy with Pembrolizumab Before Surgery for Women with Stage II Triple Negative Breast Cancer

A Phase 2a, Single-arm, Multi-center, Open-label Study of Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC Patients Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of INBRX-106, an experimental immunotherapy, with pembrolizumab (Keytruda®) PD-1 inhibitor before surgery (neoadjuvant).

Who is this for?

People with newly diagnosed stage II 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">INBRX-106, by IV, every 3 weeks for 4-5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4-5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INBRX-106 is an experimental immunotherapy that may help stimulate T cells to identify and attack 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">The combination of INBRX-106 and pembrolizumab (Keytruda®) may be used before surgery (neoadjuvant) instead of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06353997' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://inhibrx.com/inbrx-106/' target='_blank'>Inhibrx Biosciences: INBRX-106 Drug Information Page</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

NCT ID: NCT06400472

LY4170156 ADC for Advanced Triple Negative Breast Cancer

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of LY4170156, an experimental antibody drug conjugate (ADC).

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">LY4170156, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4170156 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">The antibody in LY4170156 targets folate receptor alpha and delivers a chemotherapy drug.</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/NCT06400472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://trials.lilly.com/en-US/trial/482318' target='_blank'>Eli Lilly and Company: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT06465069

LY4052031 ADC for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors (NEXUS-01) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of LY4052031, an experimental antibody drug conjugate (ADC).

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">LY4052031, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4052031 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">LY4052031's antibody targets nectin-4, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called camptothecin.</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/NCT06465069' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute at University of Utah
Salt Lake City,UT

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05464082

Predict, Prevent, and Treat Early Metastatic Recurrence of HR Low, HER2-/HER2 Low or Triple Negative Breast Cancer

Towards Functional Precision Oncology to Predict, Prevent, and Treat Early Metastatic Recurrence of Triple Negative Breast Cancer Scientific Title

Purpose

To study ways to predict, prevent, and treat early metastatic recurrence.

Who is this for?

People with stage I, stage II, or stage III hormone receptor (ER and/or PR) low, HER2 negative (HER2-) or HER2 low or triple negative (ER-, PR-, HER2-) breast cancer. You must have not yet received treatment and be planning to receive surgery and chemotherapy. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Precision oncology is treatment based on specific information from your tumor.</li> <li class="seamTextUnorderedListItem">The tumor samples will be used to complete tests to determine which treatments may be most effective.</li> <li class="seamTextUnorderedListItem">If your cancer comes back (recurrence) after surgery and chemotherapy, your doctor will receive information to help make treatment decisions.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">In this trial, hormone receptor (HR) low is defined as 1-10% of cells that are 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/NCT05464082' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: What is Precision Oncology?</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT

VISITS: 5 visits a month, ongoing

PHASE: I

NCT ID: NCT04315233

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE) Scientific Title

Purpose

To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </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/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute/University of Utah
Salt Lake City,UT

VISITS: At least 1 visit every 2 weeks

PHASE: I

NCT ID: NCT06590558

Tolinapant Targeted Therapy with Chemotherapy for Women with Advanced Triple Negative Breast Cancer

Phase I/Ib Study of Eribulin in Combination With ASTX660 (Tolinapant) in Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of tolinapant (ASTX660), an experimental targeted therapy, with eribulin (Halaven®) chemotherapy.

Who is this for?

Women 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 who have received at least 2 lines of treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tolinapant (ASTX660), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> <li class="seamTextUnorderedListItem">X-ray scans</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tolinapant (ASTX660) is an experimental targeted therapy drug that may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, needed for tumor cell survival.</li> <li class="seamTextUnorderedListItem">Chemotherapy drugs, such as eribulin (Halaven®), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.</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> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06590558' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/tolinapant-astx660-dual-iap-antagonist-t-cell-lymphomas/' target='_blank'>Astex Pharmaceuticals: Tolinapant (ASTX660) Drug Information Page</a> </li></ul>

NEAREST SITE: 602 miles
University of Utah Huntsman Cancer Institute
Salt Lake City,UT

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05490472

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of JAB-2485, an experimental Aurora A inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) ER positive (ER+), triple negative (ER-, PR-, HER2-), or ARID1A mutated 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">JAB-2485, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485 is an experimental targeted therapy called an Aurora A inhibitor. Aurora A inhibitors 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: ARID1A</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05490472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/aurora-a-kinase-inhibitor-jab-2485' target='_blank'>National Cancer Institute: JAB-2485</a> </li></ul>

NEAREST SITE: 657 miles
HonorHealth Research Institute
Scottsdale,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04787042

ST-067 for Advanced Triple Negative Breast Cancer

A Phase 1a Open-Label, Dose-Escalation, and a Phase 2 Study to Investigate the Safety, PK, PD, and Clinical Activity of ST-067 Administered Subcutaneously as Monotherapy in Patients With Relapsed or Refractory Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of ST-067, a targeted therapy.

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">ST-067, by IV</li> <li class="seamTextUnorderedListItem">2 biopsies</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ST-067 is a targeted therapy. It targets the IL-18 receptor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04787042' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 657 miles
HonorHealth Research Institute
Scottsdale,AZ

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT06171789

PRO1107 Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRO1107, an experimental antibody drug conjugate (ADC).

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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1107, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRO1107 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">The antibody in PRO1107 targets PTK7 proteins. It delivers the chemotherapy auristatin.</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/NCT06171789' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03979508

Abemaciclib Before Surgery for Women with Stage I-III, Triple Negative or ER Low, HER2- Breast Cancer That Did Not Respond to Chemotherapy

Window Trial of Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer (a BEAUTY Study*) Scientific Title

Purpose

To study the safety and effects of using the CDK 4/6 inhibitor abemaciclib (Verzenio®) after neoadjuvant chemotherapy and before surgery.

Who is this for?

Women with stage I, stage II, or stage III triple negative (ER-, PR- HER2-) or ER Low (1%-10% ER), HER2- breast cancer that did not fully respond to chemotherapy given before surgery. Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, for 2 to 3 weeks</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</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 women with triple negative as well as ER Low, HER2- breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor approved to treat HR+ and HER2- metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">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/NCT03979508' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: What Are CDK4/6 Inhibitors?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/?utm_source=google&utm_medium=ppc&campaign=6456675261&adgroup=82640243172&ad=378689406892&utm_keyword=kwd-389189556877&gclid=Cj0KCQiAmsrxBRDaARIsANyiD1qSisgRZtObbCNg3aCVnfoCwqXFjJlXYQsig6GLWR1OKy3oM7jjYJIaAtcqEALw_wcB' target='_blank'>Eli Lilly and Company Drug Information Page: Verzenio® (Abemaciclib)</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://metastatictrialtalk.org/2018/09/01/mbc-news-3/' target='_blank'>Metastatic Trial Talk: Insights Into Treatment Resistance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6523967/' target='_blank'>Journal Article: Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06055881

Radiation to Delay Treatment Changes and CTCs to Guide Treatment Options for People with Metastatic Breast Cancer

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS) Scientific Title

Purpose

To study if radiation therapy can delay treatment changes and if circulating tumor cells (CTCs) can help guide treatment options.

Who is this for?

Women with stage IV (metastatic) breast cancer who have been receiving their first line of therapy for metastatic disease for at least 1 year or have been receiving their second or later line of therapy for at least 6 months. You must have 1-3 sites of oligoprogressive disease that have not received radiation and must not have triple negative breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery or stereotactic body radiotherapy) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, CTCs may be used to help you and your doctor guide treatment options.</li> <li class="seamTextUnorderedListItem">Oligoprogressive disease refers to progression of only a few sites of metastasis.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06055881' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20555625' target='_blank'>Mayo Clinic: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/sbrt/pyc-20446794' target='_blank'>Mayo Clinic: Stereotactic Body Radiotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20071218' target='_blank'>Breastcancer.org: Circulating Tumor Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/ctc/' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic 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: 948 miles
Sarah Cannon Research Institute at HealthOne
Denver,CO

VISITS: 1 visit every 2-3 weeks

PHASE: I-II

NCT ID: NCT06526819

SMP-3124LP Targeted Therapy for Advanced Triple Negative Breast Cancer

An Open-label, Phase 1 Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SMP-3124LP in Adults with Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of SMP-3124LP, an experimental CHK1 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 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">SMP-3124LP, by IV, every 2-3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SMP-3124LP is an experimental targeted therapy called a CHK1 inhibitor. Blocking CHK1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</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/NCT06526819' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sumitomo-pharma.com/rd/pipeline_new-medicine/pipeline_profile.html' target='_blank'>Sumitomo Pharma America: SMP-3124 Drug Information Page</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: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT) Scientific Title

Purpose

To learn more about the relationship between genetic mutations and cancer outcomes.

Who is this for?

People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. Full eligibility criteria

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This is a data collection (registry) study. You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</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">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</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://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>

NEAREST SITE: 1387 miles
Oklahoma Univeristy
Oklahoma City,OK

VISITS: 1-3 visits every month

PHASE: I

NCT ID: NCT06136884

AO-252 Targeted Therapy for Advanced Triple Negative Breast Cancer with a TP53 Mutation

A First-In-Human, Phase 1 Study Evaluating Oral TACC3 PPI Inhibitor, AO-252, in Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AO-252, an experimental TACC3 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with a TP53 mutation who have received up to 4 lines of therapy for advanced disease. You must have received at least 1 line of chemotherapy for advanced disease or have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AO-252, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AO-252 is an experimental targeted therapy called a TACC3 inhibitor. TACC3 inhibitors may slow or stop cancer cells from growing.</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/NCT06136884' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.a2apharma.com/copy-of-pipeline-1' target='_blank'>A2A Pharmaceuticals: AO-252 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: NCT06781983

IPH4502 Antibody Drug Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of IPH4502, an experimental antibody drug conjugate.

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">IPH4502</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IPH4502 is an experimental 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 targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in IPH4502 targets Nectin-4 proteins. It delivers the chemotherapy MMAE.</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/NCT06781983' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.innate-pharma.com/products/iph4502-antibody-drug-conjugate' target='_blank'>Innate Pharma: IPH4502 Drug Information Page</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT06657222

TUB-030 Antibody Drug Conjugate for Advanced Triple Negative and HR+, HER2- Breast Cancer

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of TUB-030, an experimental antibody drug conjugate (ADC).

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TUB-030, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TUB-030 is an experimental 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 targets cancer cells, the ADC does minimal damage to normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in TUB-030 targets 5T4 proteins. It delivers the chemotherapy exatecan.</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/NCT06657222' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tubulis.com/our-pipeline/' target='_blank'>Tubulis: TUB-030 Drug Information Page</a> </li></ul>

NEAREST SITE: 1471 miles
NEXT Dallas
Irving,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06167317

GS-0201 Alone or With ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of GS-0201, an experimental anti-cancer therapy, alone or with sacituzumab govitecan (Trodelvy®) antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2- or HER2 low) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-0201, by mouth</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-0201 is an experimental anti-cancer therapy.</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, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06167317' target='_blank'>ClinicalTrials.gov</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: NCT04706962

Investigational Therapy TH1902 for Metastatic Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose Escalation Study of TH1902 in Patients With Advanced Solid Tumors and Expansion in Patients With Triple Negative Breast Cancer (TNBC), Gynecological Cancer, Colorectal Cancer, and Pancreatic Cancer Scientific Title

Purpose

To study the safety, dose, side effects, and anti-cancer activity of the investigational therapy TH1902.

Who is this for?

People with 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">TH1902, by IV, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TH1902 is a type of therapy called a peptide drug-conjugate (PDC).</li> <li class="seamTextUnorderedListItem">A peptide drug-conjugate combines a peptide that targets cancer cells with a therapy that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">The anti-cancer therapy in TH1902 is the commonly used chemotherapy docetaxel.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04706962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.theratech.com/products/th-1902/' target='_blank'>Thera Technologies Drug Information Page: TH1902</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/fda-grants-fast-track-designation-to-th1902-in-sort1-recurrent-advanced-solid-tumors' target='_blank'>Targeted Oncology: FDA Grants Fast Track Designation to TH1902</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
Mays Cancer Center, UT Health San Antonio
San Antonio,TX

VISITS: 3 visits within 1 month

PHASE: I

NCT ID: NCT06246786

Cyclosporin A Before Surgery for Stage I-III Triple Negative Breast Cancer

A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Cyclosporin A on Triple Negative Breast Cancer With Defective DNA Repair Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of cyclosporin A before surgery (neoadjuvant).

Who is this for?

People newly diagnosed with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer with negative or low RAD51 who have not yet received surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclosporin A, by mouth, daily, 2-4 weeks before surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclosporin A (CsA) is an experimental anti-cancer therapy that may slow or stop cancer cell growth.</li> <li class="seamTextUnorderedListItem">Cyclosporin A (CsA) is approved to help regulate the immune system for people receiving organ transplants and for some autoimmune diseases. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">RAD51 is a gene that provides instructions for making a protein that is essential for repairing damaged DNA.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06246786' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://news.uthscsa.edu/repurposed-drug-brings-new-hope-to-treat-breast-cancer-2/' target='_blank'>UT Health San Antonio: Cyclosporin for Breast Cancer</a> </li></ul>

NEAREST SITE: 1481 miles
South Texas Accelerated Research Therapeutics (START)
San Antonio,TX

VISITS: 1 visit every 2 weeks

PHASE: I

NCT ID: NCT06238479

LY4101174 ADC for Advanced Triple Negative Breast Cancer

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LY4101174, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (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">LY4101174, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4101174 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 LY4101174 targets Nectin-4 proteins. It delivers a chemotherapy drug.</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/NCT06238479' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://trials.lilly.com/en-US/trial/456635' target='_blank'>Eli Lilly and Company: Trial Information Page</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology
San Antonio,TX

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT06451497

ZM008 Targeted Therapy Alone or With Pembrolizumab for Advanced Triple Negative Breast Cancer

Phase 1 Dose Escalation Trial of ZM008, an Anti-LLT1 Antibody, as Single Agent Followed by Combination With Pembrolizumab in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and best dose of ZM008, an experimental LLT1 inhibitor, 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 who have no standard treatment options available. Full eligibility criteria

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You will be receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZM008, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZM008 is an experimental targeted therapy called a LLT1 inhibitor. Blocking LLT1 may slow or stop cancer cells from growing.</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/NCT06451497' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zumutor.com/product_pipeline/' target='_blank'>Zumutor Biologics: ZM008 Drug Information Page</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology
San Antonio,TX

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT06440005

AGX101 ADC for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors Including Triple-Negative Breast Cancer and Pancreatic Adenocarcinoma Scientific Title

Purpose

To learn about the effects and safety of AGX101, an experimental antibody drug conjugate (ADC), at various dose levels.

Who is this for?

People with advanced (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">AGX101, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AGX101 is an experimental 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 AGX101 targets TM4SF1 and delivers an anti-cancer drug.</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/NCT06440005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://angiex.com/pipeline' target='_blank'>Angiex: AGX101 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</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: I

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06008275

Neratinib and Ruxolitinib Targeted Therapy for Women with Advanced TNBC with Chest wall Recurrence

Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) and ruxolitinib (Jakafi®) targeted therapies.

Who is this for?

Women with advanced (some stage III) triple negative (ER- or ER low, PR-, HER2-) breast cancer with chest wall recurrence. You must have received at least 1 line of chemotherapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a type of anti-HER2 targeted therapy called an EGFR inhibitor. It blocks EGFR which slows or stops cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is an experimental targeted therapy called a JAK/STAT3 inhibitor. It may block JAK/STAT3 which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is approved for use in other cancers. 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/NCT06008275' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-targeted-therapy/' target='_blank'>Metastatic Trial Talk: Triple-Negative Metastatic Breast Cancer: Beyond ER, PR, and HER2</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-resistance/' target='_blank'>Metastatic Trial Talk: Discovering New Ways to Overcome Treatment Resistance in Triple-Negative MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/jakafi' target='_blank'>National Cancer Institute: Ruxolitinib (Jakafi®)</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 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 some stage III 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: 1539 miles
Mayo Clinic Health System Mankato
Mankato,MN

VISITS: At least 2 visits

PHASE: NA

NCT ID: NCT05662345

Circulating Tumor Cells Test to Make Treatment Decisions for Metastatic Breast Cancer

ACT-MBC: A Prospective Observational Impact Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer Scientific Title

Purpose

To study whether the CELLSEARCH® Circulating Tumor Cell Test helps doctors make treatment decisions and determine response to treatment.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or triple negative (ER-, PR-, HER2-) breast cancer. If you have ER+, HER2- breast cancer, you must have received at least 1 line of therapy for metastatic disease. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood sample for CELLSEARCH® Circulating Tumor Cell Test</li> </ul> followed within 1.5 years by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imaging scans, at least 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are cancer cells from a tumor that circulate in the bloodstream.</li> <li class="seamTextUnorderedListItem">The CELLSEARCH® Circulating Tumor Cell Test can detect CTCs in your blood to help your doctor make treatment decisions and determine your response to treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05662345' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/ctc/' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cellsearchctc.com/about-cellsearch/what-is-cellsearch-ctc-test' target='_blank'>Menarini Silicon Biosystems: CELLSEARCH® Circulating Tumor Cell Test</a> </li></ul>

NEAREST SITE: 1591 miles
Cox Medical Center
Springfield,MO

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03671044

Comparing an Experimental form of Docetaxel to Standard Docetaxel in Women with Advanced Triple Negative Breast Cancer

A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy Scientific Title

Purpose

To compare the safety and anti-cancer activity of Nanosomal Docetaxel Lipid Suspension (NDLS) to docetaxel (Taxotere®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have received no more than one 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">Nanosomal Docetaxel Lipid Suspension (NDLS), by IV, every 3 weeks, ongoing</li> </ul> Group 2: Standard <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Nanosomal Docetaxel Lipid Suspension (NDLS) is an experimental form of docetaxel. </li> <li class="seamTextUnorderedListItem">Research suggests that NDLS is safer than the standard form of docetaxel.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03671044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Breast Cancer Now: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/nanosomal-docetaxel-lipid-suspension' target='_blank'>NCI Drug Dictionary: Nanosomal Docetaxel Lipid Suspension</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/28255844/' target='_blank'>Journal Abstract: Nanosomal Docetaxel Lipid Suspension</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Weekly study visits during radiation treatment

PHASE: NA

NCT ID: NCT02945579

Neoadjuvant Chemo & Radiation But No Surgery for Stage I-II Triple Negative or ER Low, HER2- or HER2 Positive Breast Cancer

Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy Scientific Title

Purpose

To study the effects (good and bad) of avoiding surgery but still using radiation therapy in women whose biopsy shows their tumor disappeared after they received neoadjuvant chemotherapy.

Who is this for?

Women 40 or older with stage I or stage II triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) or HER2 positive (HER2+) breast cancer. You must have already had chemotherapy to shrink your tumor, but no other treatments Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An image-guided biopsy (a biopsy that uses imaging such as CT, ultrasound, MRI or mammography)</li> <li class="seamTextUnorderedListItem">If the biopsy does not show any evidence of disease, you will then have radiation therapy</li> <li class="seamTextUnorderedListItem">If the biopsy show evidence of disease, you will have surgery then radiation therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink tumors before surgery. The tumor may even disappear. When this occurs, researchers think it may be possible for patients to avoid surgery.</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/NCT02945579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 1621 miles
MD Anderson in The Woodlands
Conroe,TX

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT02276443

Tumor Testing Before Treatment for Stage I-III Triple Negative Breast Cancer

Improving Outcomes in Triple-Negative Breast Cancer Using Molecular Triaging and Diagnostic Imaging to Guide Neoadjuvant Therapy ARTEMIS MDACC Breast Moonshot Initiative) Scientific Title

Purpose

To study if tumor testing before treatment improves treatment response.

Who is this for?

People with newly diagnosed stage I, 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">Biomarker and molecular tumor testing</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Ultrasound, 4 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your choice of standard of care treatment or clinical trial based on testing results</li></ul>
<ul class="seamTextUnorderedList"> <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> <li class="seamTextUnorderedListItem">Studies suggest molecular testing of tumors can help guide treatment options.</li> <li class="seamTextUnorderedListItem">This study will compare tumor response of women whose treatment is guided by tumor testing results to those of women whose treatment is chosen without tumor testing.</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/NCT02276443' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2014-0185.html' target='_blank'>MD Anderson Cancer Center: ARTEMIS Trial Information Page</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06318897

Pembrolizumab Immunotherapy with Chemotherapy Before Surgery for Stage I Triple Negative Breast Cancer

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) pembrolizumab (Keytruda®) PD-1 inhibitor with carboplatin (Paraplatin®) and paclitaxel (Taxol®) chemotherapies.

Who is this for?

People with some stage I triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who 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®)</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> </ul> You will then be assigned to 1 of 2 groups based on your response to treatment: Group 1: No Cancer Detected After Neoadjuvant Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Group 2: Cancer Detected After Neoadjuvant Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxin®)</li> </ul> followed by: <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">Carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxin®) are chemotherapy drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06318897' target='_blank'>ClinicalTrials.gov</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: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT06545682

Alpelisib Targeted Therapy with Pembrolizumab Immunotherapy for Metastatic Triple Negative Breast Cancer with Active Brain Metastases

Phase Ib Study of AlpeliSib with PEmbroLizumab in Patients with MEtastatic Breast CaNcer or MelanomA (SELENA) Scientific Title

Purpose

To find a dose of the combination of alpelisib (Piqray®) targeted therapy and pembrolizumab (Keytruda®) immunotherapy that can be given to people with metastatic breast cancer.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have active and untreated brain metastases. You must have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</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 IHC 2+/FISH-.</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/NCT06545682' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Neal Cancer Center
Houston,TX

VISITS: 2 visits every 3 weeks

PHASE: II

NCT ID: NCT05660083

Targeted Therapy and Chemotherapy for Advanced Triple Negative or Metaplastic HER2 Negative Breast Cancer

Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor, L-NMMA experimental iNOS inhibitor, and nab-paclitaxel (Abraxane®) chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or metaplastic HER2 negative (HER2-) breast cancer. You must not have received treatment with everolimus (Afinitor®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">L-NMMA, by IV, 2 days every 3 weeks</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Aspirin, by mouth, daily</li> <li class="seamTextUnorderedListItem">Amlodipine, by mouth, daily, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Metformin, daily</li> <li class="seamTextUnorderedListItem">Cetirizine, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">L-NMMA is an experimental targeted therapy called a iNOS inhibitor which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Aspirin and amlodipine help prevent deep venous thrombosis (blood clots) and hypertension (high blood pressure).</li> <li class="seamTextUnorderedListItem">Metformin helps prevent hyperglycemia (high blood sugar).</li> <li class="seamTextUnorderedListItem">Cetirizine is an anti-histamine that helps prevents allergic reactions to alpelisib (Piqray®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05660083' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</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://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-015-0527-x' target='_blank'>Journal Article: iNOS Inhibition for 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: 1644 miles
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston,TX

VISITS: Coincides with routine care

PHASE: II

NCT ID: NCT05020860

Predicting the Amount of Tumor Remaining After Surgery in People with Newly Diagnosed Stage I-III Breast Cancer

A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer Scientific Title

Purpose

To study if clinical response (the amount a tumor shrinks based on imaging or a physical exam) predicts pathologic response (the amount of tumor remaining after surgery).

Who is this for?

People with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+); HER2 positive (HER2+); or triple negative (ER-, PR-, HER2-) 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 treatment based on tumor type</li> <li class="seamTextUnorderedListItem">ctDNA tests</li> <li class="seamTextUnorderedListItem">MRI scan, 2 times (for people with triple negative breast cancer)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A pathologic complete response (pCR) means that there are no cancer cells identified in the tissue removed at surgery.</li> <li class="seamTextUnorderedListItem">All treatment in this study is standard of care.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) is DNA from a tumor circulating in the bloodstream.</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/NCT05020860' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>National Cancer Institute: Pathologic Complete Response</a> </li></ul>

NEAREST SITE: 1655 miles
University of Iowa Healthcare
Iowa City,IA

VISITS: 2 visits in 1 week

PHASE: NA

NCT ID: NCT06586047

PET/CT Scans to Detect PSMA+ Cells for Women with Metastatic Triple Negative Breast Cancer

Evaluation of PSMA Expression in Triple Negative Breast Cancer Patients Using 18 F-DCFPyL-PET/CT Scientific Title

Purpose

To use PET/CT scans to measure the amount of prostate specific membrane antigen positive (PSMA+) breast cancer cells.

Who is this for?

Women with stage IV (metastatic) 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">PET/CT scan with FDG tracer, 1 time</li> </ul> followed 2-3 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with Pyl tracer, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Prostate specific membrane antigen (PSMA) is not only expressed in prostate cancer cells, but also other types of cancer cells.</li> <li class="seamTextUnorderedListItem">Researchers think that some metastatic triple negative breast cancer cells are PSMA positive (PSMA+).</li> <li class="seamTextUnorderedListItem">If so, people with metastatic triple negative breast cancer that is PSMA+ may respond to some PSMA targeted therapies.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">FDG and Pyl are radioactive tracers that are given in a vein before PET/CT scans to help identify areas of active cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06586047' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1814 miles
The West Clinic
Germantown,TN

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: 1845 miles
Loyola University Chicago
Maywood,IL

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>

NEAREST SITE: 1851 miles
Pennington Biomedical Research Center
Baton Rouge,LA

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06318507

Studying Gut Bacteria After Immunotherapy in People with Stage I-III Triple Negative Breast Cancer

The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy (IMPACT) Scientific Title

Purpose

To study how bacteria in the gut are different between women with stage I-III triple negative breast cancer who are obese and respond to immunotherapy compared to women who do not respond to immunotherapy.

Who is this for?

Women with newly diagnosed stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who are overweight or obese (BMI 25+) and have not yet received treatment. You must be planning to receive neoadjuvant (before surgery) pembrolizumab (Keytruda®). Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stool (poop) sample</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Immunotherapy drugs trigger the immune system to see, go after, and kill cancer cells.</li> <li class="seamTextUnorderedListItem">The microbiome consists of the many bacteria, viruses, and fungi found on your body.</li> <li class="seamTextUnorderedListItem">The harmful bacteria cause disease such as infection, and the beneficial bacteria help keep you healthy.</li> <li class="seamTextUnorderedListItem">Bacteria in the gut may also play a role in whether or not someone responds to immunotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06318507' target='_blank'>ClinicalTrials.gov</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: 1853 miles
Rush University Medical Center
Chicago,IL

VISITS: 2 visits within 1-2 weeks

PHASE: I

NCT ID: NCT06229392

Flu Vaccine Injected Into Tumor for Stage I-III Triple Negative or HER2+ Breast Cancer

A Phase I Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of the Fluzone influenza (flu) vaccine injected into breast tumors.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) or HER2 positive (HER2+) breast cancer who are receiving or planning to receive neoadjuvant (before surgery) chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fluzone influenza (flu) vaccine, by injection into tumor, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The flu vaccine may have anti-cancer effects for breast tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06229392' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rushu.rush.edu/news/can-flu-shot-help-fight-cancer' target='_blank'>Rush University: Can the Flu Shot Help Fight Cancer?</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>

100

NEAREST SITE: 1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis,IN

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>

101

NEAREST SITE: 1959 miles
Tennessee Oncology
Nashville,TN

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>

102

NEAREST SITE: 1959 miles
SCRI Oncology Partners
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>

103

NEAREST SITE: 1961 miles
Vanderbilt Breast Center at One Hundred Oaks
Nashville,TN

VISITS: 1 visit every 1-2 weeks

PHASE: I

NCT ID: NCT05422794

ZEN-3694 Targeted Therapy with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer that is PD-L1 Negative

A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZEN-3694, an experimental BET inhibitor, with nab-paclitaxel (Abraxane®) 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 that is PD-L1 negative who have received 0-1 lines of therapy for advanced or metastatic disease. You must not have received PD-1/PD-L1 inhibitors, nab-paclitaxel (Abraxane®), paclitaxel (Taxol®), or docetaxel (Taxotere®) for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694, by mouth, daily, 1 week</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694, by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), every 3 weeks</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT or MRI scans</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) 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">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/NCT05422794' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zenithepigenetics.com/programs/pipeline' target='_blank'>Zenith Epigenetics Drug Information Page: ZEN-3694</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><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>

104

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>

105

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

VISITS: At least 2 times in 3 months

PHASE: II

NCT ID: NCT06105684

Low Dose Capecitabine Chemotherapy for People with Advanced HR+, HER2- or Triple Negative Breast Cancer

Phase II Single Arm Trial of Low Dose Capecitabine in Patients with Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a lower dose of capecitabine (Xeloda®) chemotherapy for older or frail (weak) people with advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2- or HER2 low) or triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have received at least 1 line of therapy for advanced disease. You must be frail (weak) or at least 60 years old. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Low dose capecitabine (Xeloda®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this trial, frail is defined as having a greater risk of complications and poorer outcomes because of illness, injury, or age.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">A lower dose of capecitabine (Xeloda®) may be better for frail and older people.</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/NCT06105684' target='_blank'>ClinicalTrials.gov</a> </li></ul>

106

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

VISITS: 2 visits in 2.5 months

PHASE: NA

NCT ID: NCT05677802

Stress Management Therapy for Women with Stage I-III Triple Negative Breast Cancer

Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients Scientific Title

Purpose

To study if stress management therapy reduces stress and addresses health-related social needs.

Who is this for?

Women with newly diagnosed stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) 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">Stress management therapy, 10 sessions in 2.5 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times in 2.5 months</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The stress management therapy includes progressive muscle relaxation, coping, problem solving, communication, and social support.</li> <li class="seamTextUnorderedListItem">Health related social needs (such as utilities and transportation) will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05677802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/living-beyond-breast-cancer/life-after-breast-cancer-treatment/coping-emotionally/managing-stress-anxiety#:~:text=After%20a%20diagnosis%20of%20breast,and%20cope%20better%20with%20anxiety' target='_blank'>Breast Cancer Now: Coping with Stress Following a Breast Cancer Diagnosis</a> </li></ul>

107

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

VISITS: 3 visits within 1 month

PHASE: I

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>

108

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

VISITS: At least 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT06460298

ProAgio Targeted Therapy with Chemotherapy for Advanced Triple Negative Breast Cancer

Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of ProAgio, an experimental targeted therapy, with gemcitabine (Gemzar®) chemotherapy.

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-) breast cancer who have received at least 2 lines of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ProAgio, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ProAgio is an experimental targeted therapy called an αVβ₃ inhibitor. αVβ₃ inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06460298' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://research.gsu.edu/startup/proda-biotech/' target='_blank'>Georgia State University: ProAgio</a> </li></ul>

109

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>

110

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

VISITS: About 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05741164

Propranolol and Pembrolizumab for Women with Advanced Triple Negative Breast Cancer

Impact of Beta-2 Adrenergic Blockade With Checkpoint Inhibition in Checkpoint Inhibitor Refractory Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study if propranolol, a high blood pressure drug, can improve the anti-cancer activity of pembrolizumab (Keytruda®), a PD-1 inhibitor.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received chemotherapy with pembrolizumab (Keytruda®) for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">Questionaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol is a beta blocker drug used to treat high blood pressure and heart problems.</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">Beta blockers, including propranolol, may reduce the effects of some stress hormones produced by the body during cancer treatment. This process may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by 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/NCT05741164' target='_blank'>ClinicalTrials.gov</a> </li></ul>

111

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>

112

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>

113

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>

114

NEAREST SITE: 2314 miles
Wake Forest Baptist Health Sciences
Winston-Salem,NC

VISITS: 1 visit every 1-3 weeks for up to 5 months

PHASE: II

NCT ID: NCT04677816

Vitamin D with Chemotherapy Before Surgery for People with Triple Negative Breast Cancer

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of vitamin D with standard of care doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®) neoadjuvant (before surgery) chemotherapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who are receiving or planning to receive chemotherapy before surgery (neoadjuvant). Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental for People With Vitamin D Deficiency <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li> <li class="seamTextUnorderedListItem">Vitamin D3, by mouth, weekly for 5 months</li> <li class="seamTextUnorderedListItem">Drug diary</li> </ul> Group 2: Standard of Care for People Without Vitamin D Deficiency <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®) are chemotherapy drugs.</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+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04677816' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/diet-nutrition/dietary-supplements/known/vitamin-d' target='_blank'>Breastcancer.org: Vitamin D and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/integrative-medicine/herbs/vitamin-d#:~:text=A%20meta%2Danalysis%20of%20vitamin,supportive%20hazard%20ratio%20(90).' target='_blank'>Mayo Clinic: Vitamin D</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

115

NEAREST SITE: 2380 miles
Morton Plant Hospital - Baycare Health System
Clearwater,FL

VISITS: 5 doses per week for 3-6 weeks

PHASE: II

NCT ID: NCT05528133

Personalizing Radiation Therapy for Stage I-III Triple Negative Breast Cancer

Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of using the radiosensitivity index to personalize treatment with radiation therapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who have received a lumpectomy and lymph node biopsy. 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">Radiation based on radiosensitivity index, 5 doses per week for 3-6 weeks</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 5 doses per week for 4-6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <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">The radiosensitivity index is a test that evaluates 10 genes to determine the sensitivity of a tumor to radiation. This test may help personalize the radiation dose for a person.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05528133' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/newsroom/press-release-archive/moffitt-researchers-develop-model-to-personalize-radiation-treatment-for-breast-cancer-patients/' target='_blank'>Moffitt Cancer Center: Radiosensitivity Index</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

116

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT06349642

Registry to Predict Response to Immune Checkpoint Inhibitors for People with Stage I-IV Breast Cancer

Observational Basket Study to Predict Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform (CYBRID-04) Scientific Title

Purpose

To create a registry to predict response to treatment with immune checkpoint inhibitors.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with TMB, MSI-H, or dMMR mutations who are planning to receive pembrolizumab (Keytruda®) or dostarlimab (Jemperli®). If you have stage I, stage II, or stage III breast cancer, you must have not yet received treatment. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy sample</li> <li class="seamTextUnorderedListItem">Blood sample</li></ul>
<ul class="seamTextUnorderedList"> <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">Pembrolizumab (Keytruda®) and dostarlimab (Jemperli®) are types of immunotherapy called PD-1 inhibitors, which are 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">MSI-H and dMMR mutations include MLH1, MSH2, MSH6, and PMS2.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TMB, MSI-H, dMMR, MLH1, MSH2, MSH6, PMS2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06349642' target='_blank'>ClinicalTrials.gov</a> </li></ul>

117

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

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

PHASE: I-II

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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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>

118

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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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>

119

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 6 visits within up to 1 year

PHASE: I

NCT ID: NCT06435351

Personalized Vaccine After Surgery for Stage II-III Triple Negative Breast Cancer

Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a personalized breast cancer vaccine.

Who is this for?

People with stage II or some stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have residual disease after neoadjuvant (before surgery) chemotherapy and surgery. You must have completed treatment less than 1.5 years ago. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> <li class="seamTextUnorderedListItem">Genomic sequencing of tumor sample</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, 3 times within 1.5 months, then up to 2 times within 1 year</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 leukapheresis. These cells are processed in a lab so that they will see and go after cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells 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/NCT06435351' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/immunotherapy/types/vaccines-to-treat-cancer#:~:text=Dendritic%20cell%20vaccines,system%20to%20attack%20the%20cancer.' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li></ul>

120

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>

121

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: At least 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT06238921

ADC, Targeted Therapy, and Stereotactic Radiation for Metastatic Triple Negative Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stereotactic radiation, sacituzumab govitecan (Trodelvy®) antibody drug conjugate, and zimberelimab experimental targeted therapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer that has spread to the brain (brain metastasis) and who have at least 1 brain lesion that has not been treated with radiation. You must have received chemotherapy with doxorubicin (Adriamycin®) and at least 1 of the following: paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation</li> </ul> followed 1 week later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Zimberelimab, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Imaging scans, every 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</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">Zimberelimab is an experimental targeted therapy 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/NCT06238921' 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://www.cancer.gov/publications/dictionaries/cancer-drug/def/zimberelimab' target='_blank'>National Cancer Institute: Zimberelimab</a> </li></ul>

122

NEAREST SITE: 2406 miles
University of North Carolina
Chapel Hill,NC

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT06347068

CAR-T Cells for Advanced Triple Negative Breast Cancer

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer Scientific Title

Purpose

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

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. 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">CAR-T cell therapy, by IV</li></ul>
<ul class="seamTextUnorderedList"> <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 B7-H3 expressing cancer cells.</li> <li class="seamTextUnorderedListItem">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/NCT06347068' 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: 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>

124

NEAREST SITE: 2437 miles
Penn State Health College of Medicine
Hershey,PA

VISITS: 5 visits within up to 5 years

PHASE: I

NCT ID: NCT05957042

Ultrasound to Predict Response to Chemotherapy and Immunotherapy for Stage I-IV Triple Negative Breast Cancer

Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI). Scientific Title

Purpose

To study if ultrasound with sulfur hexafluoride (Lumason®) can predict response to chemotherapy and immunotherapy.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive chemotherapy and immunotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sulfur hexafluoride (Lumason®), by IV, 4 times within up to 5 years</li> <li class="seamTextUnorderedListItem">Ultrasound, 5 times within up to 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sulfur hexafluoride (Lumason®) is a tracer that can look for and attach to cancer cells which improves visibility in an ultrasound.</li> <li class="seamTextUnorderedListItem">Sulfur hexafluoride (Lumason®) is approved for use in other conditions. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Ultrasounds use sound waves to produce images of structures within your body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05957042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.everydayhealth.com/drugs/sulfur-hexafluoride' target='_blank'>Everyday Health: Sulfur Hexafluoride for Ultrasound</a> </li></ul>

125

NEAREST SITE: 2452 miles
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore,MD

VISITS: 1 visit every 2 weeks

PHASE: I

NCT ID: NCT05627960

AG01 Targeted Therapy for Advanced HER2-/HER2 Low Breast Cancer That Expresses GP88

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AG01, an experimental PGRN/GP88 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer that expresses GP88. You must have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01 is an experimental targeted therapy called a PGRN/GP88 inhibitor. Blocking PGRN/GP88 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: GP88</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05627960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abstractsonline.com/pp8/#!/10462/presentation/1702' target='_blank'>SABCS 2021 Abstract: AG01 Inhibits Growth of Triple Negative Breast Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/33616772/' target='_blank'>Journal Article: AG01 Inhibits Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>

126

NEAREST SITE: 2453 miles
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore,MD

VISITS: At least 8 visits

PHASE: II

NCT ID: NCT06245889

Chemo-Immunotherapy for People Newly Diagnosed with Stage II-III Triple Negative Breast Cancer

A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics (NeoADAPT) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of paclitaxel (Taxol®) and carboplatin (Paraplatin®) chemotherapy with pembrolizumab (Keytruda®) PD-1 inhibitor, as well as further treatment based on treatment response.

Who is this for?

People with stage II or 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 receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">PET scan, 2 times</li> <li class="seamTextUnorderedListItem">ctDNA tests, 4 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 4 cycles</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 cycles</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), 4 cycles</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if complete response) or additional chemotherapy (if residual disease)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receiving chemotherapy with immunotherapy is called chemo-immunotherapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs.</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 present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Complete response to no cancer cells present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer to look for signs of disease, including cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06245889' target='_blank'>ClinicalTrials.gov</a> </li></ul>

127

NEAREST SITE: 2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia,PA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04523857

Abemaciclib CDK4/6 Inhibitor With or Without Hydroxychloroquine for Stage I-III Breast Cancer At Risk of Recurrence

A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY") Scientific Title

Purpose

To study the safety, effects (good and bad), and ability of abemaciclib (Verzenio®) CDK4/6 inhibitor with and without hydroxychloroquine (Plaquenil®), an experimental cancer drug, to reduce or eliminate breast cancer cells in the bone marrow.

Who is this for?

People with stage I, stage II, or stage III breast cancer who completed treatment and have one of the following recurrence risk factors: 1) lymph node positive; 2) triple negative (ER-, PR-, HER2-); 3) estrogen receptor positive (ER+), HER2 negative (HER2-), lymph node negative; 4) leftover tumor found in your breast or lymph node (residual disease) after neoadjuvant (before surgery) chemotherapy. You must not have received treatment with a CDK4/6 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">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®) is an experimental cancer drug that may help cancer drugs work better.</li> <li class="seamTextUnorderedListItem">The drugs may target bone marrow disseminated tumor cells (DTCs).</li> <li class="seamTextUnorderedListItem">This trial requires bone marrow testing through another research study.</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/NCT04523857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://i2b.us/repurposing-drugs-as-expanding-cancer-treatment-palette-hydroxychloroquine/' target='_blank'>Institute of Integrative BioOncology: Hydroxychloroquine for Cancer</a> </li></ul>

128

NEAREST SITE: 2519 miles
Thomas Jefferson University Hospital
Philadelphia,PA

VISITS: 5 visits

PHASE: NA

NCT ID: NCT04959474

Reducing Calories During Radiation Therapy for DCIS or Stage I-III Breast Cancer

SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer Scientific Title

Purpose

To determine if neoadjuvant (before surgery) calorie restriction during radiation therapy decreases the size of tumor tissue, compared to radiation therapy alone.

Who is this for?

People age 40 and older with DCIS, stage I, stage II, or stage III node negative breast cancer or age 50 and older if you have triple negative (ER-, PR-, HER2-) breast cancer. You must have not yet received chemotherapy, radiation, or surgery. Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic ablative radiation therapy (SABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ.</li> <li class="seamTextUnorderedListItem">Giving SABR before surgery may make the tumor smaller.</li> <li class="seamTextUnorderedListItem">Adding dietary restriction to radiation therapy may help increase the effectiveness of the radiation and decrease the spread of the cancer to other places in the body.</li> <li class="seamTextUnorderedListItem">The reduced calorie diet consists of reducing your calorie intake by 25%.</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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04959474' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stanfordhealthcare.org/medical-treatments/s/stereotactic-body-radiation-therapy.html#:~:text=Stereotactic%20ablative%20radiotherapy%20(SABR)%2C,dose%20to%20the%20surrounding%20organs.' target='_blank'>Stanford: Stereotactic Ablative Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.jefferson.edu/university/jmc/departments/radiation_oncology/news/07212014.html' target='_blank'>Thomas Jefferson University: Calorie Restriction and Breast Cancer</a> </li></ul>

129

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 0-2 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>

130

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

VISITS: 1 visit every 1-2 weeks

PHASE: II

NCT ID: NCT05570253

Evexomostat and Chemotherapy for People with Advanced Triple Negative Breast Cancer and High Blood Sugar or High BMI

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of eribulin (Halaven®) chemotherapy with or without evexomostat (SDX-7320), an experimental polymer drug conjugate.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2- or HER2 low) breast cancer who have high blood sugar or a BMI of at least 30 kg/m^2. You must have received chemotherapy and must not have received more than 2 lines of therapy for advanced or 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">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320), by injection, every 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for evexomostat (SDX-7320)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug.</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/NCT05570253' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aretha1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>

131

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>

132

NEAREST SITE: 2548 miles
RWJBarnabas Health - Robert Wood Johnson University Hospital
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>

133

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>

134

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

VISITS: 10 visits within 5 years

PHASE: II

NCT ID: NCT05949021

Chemotherapy After Surgery for Women with Stage I-II Triple Negative Breast Cancer

OCTANE: Adjuvant Liposomal Doxorubicin and Carboplatin for Early-stage Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) chemotherapy after surgery (adjuvant).

Who is this for?

Women with stage I or stage II triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have received surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), monthly for 4 months</li> <li class="seamTextUnorderedListItem">ctDNA tests, 7 visits within 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) and carboplatin (Paraplatin®) are chemotherapy drugs commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin (Adriamycin®) is doxorubicin (Adriamycin®) in tiny spheres that keep the drug in the bloodstream longer so that more drug reaches the cancer cells.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">This trial is also studying the use of ctDNA to detect treatment response and disease progression.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH negative.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05949021' 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.cancerresearchuk.org/about-cancer/treatment/drugs/liposomal-doxorubicin' target='_blank'>Cancer Research UK: Liposomal Doxorubicin (Adriamycin®)</a> </li></ul>

135

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>

136

NEAREST SITE: 2567 miles
Mt Sinai Chelesa
New York,NY

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03709446

Leflunomide in Previously Treated Metastatic Triple Negative & ER Low Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers Scientific Title

Purpose

To determine the safety and effects (good and bad) of leflunomide (Arava®), an oral drug that blocks dihydroorotate dehydrogenase (DHODH).

Who is this for?

Women with metastatic (stage IV) triple negative (ER-,PR-,HER2-) or ER Low (1%-10% ER) breast cancer who have had no more than 2 chemotherapies used to treat metastases. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leflunomide (Arava®), by mouth, daily</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 women with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Leflunomide (Arava®) is approved to treat certain adults with rheumatoid arthritis.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03709446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/leflunomide-oral-route/description/drg-20067158' target='_blank'>Mayo Clinic: Drugs and Supplements Leflunomide (Oral Route)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2017/12/171219092956.htm' target='_blank'>Science Daily:Arthritis drug could help treat advanced skin cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncologynurseadvisor.com/home/cancer-types/breast-cancer/immunosuppressor-inhibits-metabolic-pathway-in-breast-cancer-kills-cancer-cells/' target='_blank'>Oncology Nurse Advisor: Immunosuppressor Inhibits Metabolic Pathway in Breast Cancer, Kills Cancer Cells</a> </li></ul>

137

NEAREST SITE: 2569 miles
Brooklyn Methodist Hospital - NewYork Presbyterian
New York,NY

VISITS: Coincides with routine care and surgery

PHASE: NA

NCT ID: NCT05134779

Tumor Registry for Triple Negative Breast Cancer

De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You Scientific Title

Purpose

To create a large registry of tumor samples, called a biobank or tumor bank, to help researchers study triple negative breast cancer and discover new treatments.

Who is this for?

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

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You will provide the following at different timepoints during your treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Tumor samples (during surgery)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood and tumor samples will be taken at the following timepoints (if relevant): diagnosis, surgery, recurrence, and/or metastasis.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05134779' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/triple-negative' target='_blank'>Breastcancer.org: Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://seer.cancer.gov/registries/cancer_registry/index.html' target='_blank'>National Cancer Institute: What is a Cancer Registry?</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

138

NEAREST SITE: 2569 miles
Columbia University Irving Medical Center
New York,NY

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 40 and Older Having a Lumpectomy

Differential Comparison of the Breast Tumor Microenvironment Between Luminal A and Triple Negative Breast Cancer With and Without Radiation Treatment Scientific Title

Purpose

To study the healthy tissue surrounding your tumor to determine if this tissue affects how your cancer cells behave.

Who is this for?

Women with stage 0 (DCIS), stage I, stage II, or some stage III HER2 negative (HER2-) breast cancer. You must also be 40 or older, have had a mammogram within the past six months, and be receiving treatment at the Breast Surgery and Radiation Oncology Clinics of Columbia University. Full eligibility criteria

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During surgery <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 tissue and blood samples will be collected</li> <li class="seamTextUnorderedListItem">Samples will be collected before and after you receive radiation during surgery</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03165487' target='_blank'>ClinicalTrials.gov</a> </li></ul>

139

NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH

VISITS: At least 1 visit every 3-6 weeks

PHASE: I-II

NCT ID: NCT06134375

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

Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: a Randomized Phase II Study of Tetrathiomolybdate (TM) Plus Capecitabine in Patients with Breast Cancer At High Risk of Recurrence Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of tetrathiomolybdate, an experimental copper depletion (removal) drug, with standard of care capecitabine (Xeloda®) chemotherapy and pembrolizumab (Keytruda®) PD-1 inhibitor.

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 received chemotherapy before surgery (neoadjuvant) and surgery within the last 3 months. You must also either have node positive disease after treatment or have a Residual Cancer Burden (RCB) score of 2 or 3. 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">Tetrathiomolybdate, by mouth, daily for 3 years</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 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 for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tetrathiomolybdate is a drug that removes copper from the body (copper depletion) and is used to treat other diseases and some advanced cancers.</li> <li class="seamTextUnorderedListItem">Removing copper from the body may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Adding tetrathiomolybdate to standard of care treatment may make the treatment more effective.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) 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> <li class="seamTextUnorderedListItem">Node positive means that cancer has spread to the lymph nodes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06134375' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/copper-depletion-combats-metastatic-recurrence-in-high-risk-tnbc' target='_blank'>OncLive: Tetrathiomolybdate for Triple Negative Breast Cancer</a> </li></ul>

140

NEAREST SITE: 2685 miles
Massachusetts General Hospital at Newton-Wellesley Hospital
Newton,MA

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT04230109

Sacituzumab Govitecan Before Surgery for Stage I-III Triple Negative Breast Cancer

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR) Scientific Title

Purpose

To study the anti-cancer activity and safety of the targeted therapy sacituzumab govitecan (Trodelvy) in early-stage triple negative breast cancer.

Who is this for?

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

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic (stage IV) triple negative breast cancer. Its use in people with early stage triple negative breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">It 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 sacituzumab govitecan targets TROP2 proteins and delivers the chemotherapy irinotecan. Irinotecan is approved for use in many 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/NCT04230109' 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.org/cancer/breast-cancer/treatment/treatment-of-triple-negative.html' target='_blank'>American Cancer Society: Treatment of Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/trip_neg' target='_blank'>Breastcancer.org: Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/patient/home' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer' target='_blank'>FDA Drug Approvals and Databases: Sacituzumab Govitecan-hziy for Metastatic TNBC</a> </li></ul>

141

NEAREST SITE: 2693 miles
Massachusetts General Hospital Cancer Center
Boston,MA

VISITS: Weekly visits for 2 out of every 3 weeks

PHASE: I-II

NCT ID: NCT04039230

Sacituzumab Govitecan and Talazoparib for Women With Metastatic Triple Negative Breast Cancer

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To evaluate the safety, best dose, and effects (good and bad) of using PARP inhibitor talazoparib (Talzenna®) in combination with sacituzumab govitecan (Trodelvy).

Who is this for?

Women with 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">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, once a week, for 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is talazoparib (Talzenna®). It is approved for use in individuals with advanced triple-negative breast cancer and an inherited BRCA1 or BRCA2 mutation. </li> <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 to treat some metastatic triple-negative breast cancer, 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/NCT04039230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/news/april-2020/fda-approves-sacituzumab-govitecan-hziy-for-patients-with-previously-treated-metastatic-triple-negative-breast-cancer/' target='_blank'>ASCO: FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunomedics.com/sacituzumab-govitecan-immu-132/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109819878' target='_blank'>Pfizer Oncology: Talzenna™</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: ADCs in Breast Cancer</a> </li></ul>

142

NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA

VISITS: At least 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT06351332

Azenosertib Targeted Therapy with Chemotherapy and Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of azenosertib (ZN-C3), an experimental targeted therapy, with carboplatin (Paraplatin®) chemotherapy and pembrolizumab (Keytruda®) PD-1 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 who have received 1-3 lines of chemotherapy for advanced disease, including 1 antibody drug conjugate (ADC). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azenosertib (ZN-C3), by mouth, daily, 5 days on, 2 days off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 4 times in 7 months, then every 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azenosertib (ZN-C3) is an experimental targeted therapy called a WEE1 inhibitor. Blocking WEE1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">WEE1 is an important protein in tumor growth.</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. It is currently approved only for PD-L1 positive cancer.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug commonly used to treat breast cancer. it is considered standard of care for breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</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/NCT06351332' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zentalis.com/pipeline/pipeline' target='_blank'>Zentalis Pharmaceuticals: Azenosertib Drug Information Page</a> </li></ul>

143

NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA

VISITS: 1 visit every 6 months, for 2 years

PHASE: NA

NCT ID: NCT04030507

Using MRIs to Screen for Brain Metastases in Advanced Breast Cancer

Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study Scientific Title

Purpose

To study if using MRIs to screen for brain metastases (breast cancer that has spread to the brain) is safe and finds brain metastases earlier than the standard of care (no screening).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who will be starting their first or second chemotherapy for advanced disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups depending upon your cancer subtype: Group 1: Triple negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> Group 2: Inflammatory <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> Group 3: Hormone positive or HER2 positive People in Group 3 will be randomly assigned to receiving screening or no screening Screening group <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI, every 6 months for 2 years</li> </ul> No screening group <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No brain MRIs</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain metastases (brain mets) is when breast cancer has spread to the brain. </li> <li class="seamTextUnorderedListItem">The standard of care for metastatic breast cancer does not include ongoing screening for brain metastases.</li> <li class="seamTextUnorderedListItem">This imaging trial will use regularly scheduled MRIs (magnetic resonance imaging) to look for brain mets.</li> <li class="seamTextUnorderedListItem">Researchers believe adding brain metastases screening to the standard of care will help doctors find brain mets earlier--when they are smaller and potentially easier to manage.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04030507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/mri/about/pac-20384768' target='_blank'>Mayo Clinic: Brain MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologybusiness.com/topics/policy/brain-mri-could-id-metastases-breast-cancer-patients-guidelines-dont-recommend-it' target='_blank'>Radiology Business: Brain MRI Could ID Metastases in Breast Cancer Patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/Spring2019/Looking-for-Brain-Metastases.aspx' target='_blank'>Cancer Today: Looking for Brain Metastases</a> </li></ul>

144

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT06582615

Healthy Eating and Nutrition Counseling to Improve Cognition During Chemotherapy for Women with Stage II-III Triple Negative Breast Cancer

Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer (MIND-TNBC) Scientific Title

Purpose

To study if the MIND eating plan can improve memory and mental function, fatigue, sleep quality, anxiety, and depression.

Who is this for?

Women 40-65 years old with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who are receiving (within the past 6 months) or planning to receive chemotherapy before surgery (neoadjuvant). Full eligibility criteria

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What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MIND counseling sessions, virtual, weekly for 1 month, then every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Personalized eating plan, 3 months</li> <li class="seamTextUnorderedListItem">Wear a FitBit</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 6 months</li> <li class="seamTextUnorderedListItem">Surveys</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health sessions, virtual, weekly for 1 month, then every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Wear a FitBit</li> <li class="seamTextUnorderedListItem">Cognitive tests, 2 times in 6 months</li> <li class="seamTextUnorderedListItem">Surveys</li> </ul> followed 6 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MIND counseling sessions, virtual, weekly for 1 month, then every 2 weeks for 2 months</li> <li class="seamTextUnorderedListItem">Personalized eating plan, 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cancer treatment can lead to cognition (ability to think) problems and low quality of life.</li> <li class="seamTextUnorderedListItem">The Neurodegenerative Delay (MIND) eating plan is high in anti-inflammatory nutrients (omega-3, carotenoids, B vitamins, etc.) and limits foods that are not healthy for the brain (butter, cheese, red meat, fried foods, sugar, etc.).</li> <li class="seamTextUnorderedListItem">The MIND eating plan may help improve brain function during cancer treatment.</li> <li class="seamTextUnorderedListItem">In this trial, you will be sent some of the main foods in the MIND eating plan.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06582615' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.osu.edu/wellness/exercise-and-nutrition/the-mind-diet' target='_blank'>Ohio State University: The MIND Diet and Brain Health</a> </li></ul>