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Find Breast Cancer Clinical Trials That Are Right For You

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

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(Last updated: May 07, 2026)

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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
University of California San Francisco
San Francisco,CA

VISITS: At least 1 visit every 2 weeks

PHASE: II

NCT ID: NCT04434040

Immunotherapy and Targeted Therapy After Chemo and Surgery to Prevent Recurrence in Stage I-III Triple Negative Breast Cancer

Combination Ipatasertib and Atezolizumab to Prevent Recurrence in Triple Negative Breast Cancer Scientific Title

Purpose

To study if receiving the immunotherapy atezolizumab (Tecentriq®) in combination with the targeted therapy ipatasertib after receiving neoadjuvant chemotherapy and surgery helps prevent recurrence.

Who is this for?

People who received chemotherapy before surgery for triple negative (ER-, PR-, HER2-) breast cancer and were found to still have tumor cells in a breast or lymph node and have evidence of circulating tumor DNA (cfDNA) in their blood. You must be within 1 year of finishing treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It is approved for use in women with advanced and metastatic triple negative breast cancer. Its use in early-stage breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Ipatasertib is a type of targeted therapy called an AKT inhibitor. AKT is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA tests look for evidence of breast cancer cells that have left the tumor and are moving through the bloodstream.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04434040' 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/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>NCI Dictionary of Cancer Terms: Pathological Complete Response</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/ipatasertib-survival-results-continue-to-impress-in-tnbc' target='_blank'>OncLive: Ipatasertib Survival Results Continue to Impress in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab Approved for Some Patients with Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20191218/circulating-tumor-dna-predicts-recurrence-in-earlystage-triplenegative-breast-cancer' target='_blank'>HemOnc Today: Circulating Tumor DNA Predicts Recurrence in Early-Stage TNBC</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: 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 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
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
San Francisco,CA

VISITS: At least 1 visit every 1-4 weeks

PHASE: III

NCT ID: NCT06841354

Sacituzumab Tirumotecan ADC With and Without Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing..(MK-2870-011) (TroFuse-011) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab tirumotecan, an experimental antibody drug conjugate (ADC), alone or with pembrolizumab (Keytruda®) immunotherapy compared to standard of care chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment for advanced disease. Your cancer must express PD-L1 at a combined positive score (CPS) of less than 10. 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">Sacituzumab tirumotecan (Sac-TMT, MK-2870), by IV, every 2 weeks</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (Sac-TMT, MK-2870), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> </ul> Group 3: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy, by IV, every 1-4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan 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">Sacituzumab tirumotecan's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06841354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/july-10-2024/novel-antibody-drug-conjugate-extends-survival-vs-chemotherapy-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Sacituzumab Tirumotecan ADC Extends Survival vs. Chemotherapy in Triple Negative Breast Cancer</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
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: 3 miles
Kaiser Permanente - San Francisco ( Site 0080)
San Francisco,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: 28 miles
Stanford Women's Cancer Center
Palo Alto,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: 28 miles
Stanford University
Palo Alto,CA

VISITS: At least 2 visits in 1 week

PHASE: NA

NCT ID: NCT04981119

Studying HLA Gene Changes and Storing Immune Cells for Future Immunotherapy for Advanced Triple Negative Breast Cancer

An Observational Study Obtaining Solid Tumor Tissue from Participants and Apheresis for CAR T-Cell Therapy Manufacturing (BASECAMP-1) Scientific Title

Purpose

To study if tumors have HLA gene changes and to store immune cells that will be used to create a future immunotherapy treatment.

Who is this for?

People with some stage III (advanced) or 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">Blood or saliva (spit) sample for HLA gene testing</li> <li class="seamTextUnorderedListItem">Apheresis</li> <li class="seamTextUnorderedListItem">CAR T-cell therapy if the cancer comes back</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">One reason tumors may grow is because of changes in the HLA gene.</li> <li class="seamTextUnorderedListItem">When HLA is mutated (changed), your immune system loses the ability to recognize the cancer.</li> <li class="seamTextUnorderedListItem">Apheresis is a type of blood draw that collects white blood cells.</li> <li class="seamTextUnorderedListItem">CAR-T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your cells will be stored to create a CAR T-cell therapy if your cancer returns.</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/NCT04981119' target='_blank'>ClinicalTrials.gov</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: 28 miles
Stanford University Medical Center
Palo Alto,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: 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: 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: 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: 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 Comprehensive Cancer 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
Research Site
Sacramento,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: 182 miles
Cancer Care Specialist of Reno
Reno,NV

VISITS: Number of visits unavailable, up to 5 years

PHASE: NA

NCT ID: NCT07211178

Blood Tests to Monitor for Cancer Coming Back for Stage I-III Triple Negative or Stage II-III HR+ or HER2+ Breast Cancer

Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies Scientific Title

Purpose

To study if detecting minimal residual disease (MRD) can help predict if a patient's cancer will return and if the treatment is working.

Who is this for?

People with stage I, stage II, or some stage III triple negative (ER-, PR-, HER2-) or stage II or some stage III HER2 positive (HER2+) or stage II or some stage III hormone receptor positive (ER+ and/or PR+) breast cancer. People with hormone receptor positive, HER2- cancer must also have 4 or more positive lymph nodes or 1-3 positive lymph nodes and either grade 3 disease or tumor size of 5 cm or larger. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests for MRD monitoring</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tiny bits of cancer DNA that are shed into the blood are called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. The presence of ctDNA in the blood is called minimal residual disease (MRD). MRD can lead to the cancer coming back later.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07211178' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 186 miles
Renown Regional Medical Center ( Site 0041)
Reno,NV

VISITS: Every 1-3 weeks for 1.5 years

PHASE: III

NCT ID: NCT06966700

Sacituzumab Tirumotecan, Pembrolizumab, and Chemotherapy for Stage I-III Triple Negative or HR Positive Low, HER2- Breast Cancer

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Grow... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab tirumotecan antibody-drug conjugate, pembrolizumab (Keytruda®) immunotherapy, and chemotherapy compared to pembrolizumab (Keytruda®) immunotherapy and chemotherapy.

Who is this for?

People with some stage I, stage II, or some stage III triple-negative (ER-, PR-, HER2-) or hormone receptor low positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment for their breast cancer. 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 tirumotecan, by IV, every 2 weeks for 4 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4 months</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, weekly</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Radiation (if recommended)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy (optional)</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, weekly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 1.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4 months</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 3 weeks for 4 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Radiation (if recommended)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy (optional)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HR-low+ is defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells.</li> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan is an antibody-drug conjugate (ADC), which 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">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06966700' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 336 miles
Exelixis Clinical Site #19
Los Angeles,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: 336 miles
UCLA Health
Los Angeles,CA

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT06827613

Invikafusp Alfa Immunotherapy with ADC for Advanced Triple Negative or HR+, HER2- Breast Cancer

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of STAR0602, an experimental immunotherapy, 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-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Invikafusp alfa (STAR0602), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Invikafusp alfa (STAR0602) is an experimental bispecific antibody that may target immune cells to stimulate anti-cancer activity.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06827613' target='_blank'>ClinicalTrials.gov</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://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: 336 miles
University of California, Los Angeles (UCLA)
Los Angeles,CA

VISITS: At least 1 visit every month

PHASE: I-II

NCT ID: NCT04115306

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ 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 study the safety, best dose, and effects (good and bad) of PMD-026, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), RSK2 positive (RSK2+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental targeted therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</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></ul>

NEAREST SITE: 339 miles
Providence Saint John's Health Center
Santa Monica,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: 339 miles
UCLA Hematology/Oncology - Parkside ( Site 0021)
Santa Monica,CA

VISITS: Every 1-3 weeks for 1 year

PHASE: II

NCT ID: NCT06797635

Patritumab Deruxtecan ADC with Immunotherapy and Chemotherapy for Stage II-III Triple Negative or HR Low, HER2- Breast Cancer

An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or H... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan, an experimental antibody drug conjugate (ADC), with pembrolizumab (Keytruda®) immunotherapy and chemotherapy before surgery.

Who is this for?

People with stage II or some 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 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by after surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks for 7.5 months</li> <li class="seamTextUnorderedListItem">Additional treatment (if needed)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks for 3 months</li> </ul> followed by after surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks for 7.5 months</li> <li class="seamTextUnorderedListItem">Additional treatment (if needed)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubin (Adriamycin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> </ul> followed by after surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 6 weeks for 7.5 months</li> <li class="seamTextUnorderedListItem">Additional treatment (if needed)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan 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">Patritumab deruxtecan's antibody targets HER3, a protein that is expressed by some breast cancer cells, and it delivers the anti-cancer drug deruxtecan.</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">Paclitaxel (Taxol®), carboplatin (Paraplatin®), doxorubin (Adriamycin®), and cyclophosphamide (Cytoxan®) 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/NCT06797635' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/neoadjuvant-patritumab-deruxtecan-letrozole-shows-efficacy-in-high-risk-hr-her2-breast-cancer' target='_blank'>OncLive: Patritumab Deruxtecan for Advanced Breast Cancer</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Medical Center
Los Angeles,CA

VISITS: May require hospitalization

PHASE: I-II

NCT ID: NCT06682793

A2B395 CAR T Cell Therapy for Advanced Breast Cancer That Expresses EGFR and Has Lost HLA Expression

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression (DENALI-1 (after BASECAMP-1)) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad), and anti-cancer activity of A2B395, an experimental CAR T cell immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses EGFR (EGFR+) and has lost HLA-A*02 expression. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A2B395</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To participate in this study, your tumor will be tested for EGFR and HLA by also enrolling into the BASECAMP-1 trial (NCT04981119).</li> <li class="seamTextUnorderedListItem">HLA-A*02 is a marker found on cancer cells that plays a role in how the immune system responds to cancer.</li> <li class="seamTextUnorderedListItem">EGFR (epidermal growth factor receptor) is a protein that is involved in cell growth and survival. </li> <li class="seamTextUnorderedListItem">A2B395 is an experimental CAR T cell immunotherapy.</li> <li class="seamTextUnorderedListItem">CAR T cell or CAR-T cell therapy is an immunotherapy made from white blood cells.</li> <li class="seamTextUnorderedListItem">The blood cells are removed and modified in a lab with chimeric antigen receptors (CARs) so that they can attack a specific protein on cancer cells.</li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused into you while you are hospitalized.</li> <li class="seamTextUnorderedListItem">In this trial, the cells will attack cancer cells that express EGFR and have lost HLA-A*02 expression. Normal healthy cells will not be targeted.</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/NCT06682793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy-mbc-2-2/' target='_blank'>Metastatic Trial Talk: Cell-Based Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

NEAREST SITE: 340 miles
Valkyrie Clinical Trials
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II-III

NCT ID: NCT06926868

Izalontamab Brengitecan Versus Chemotherapy for Advanced Triple Negative or ER Low Breast Cancer

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of izalontamab brengitecan, a bi-specific antibody-drug conjugate (ADC), compared to standard chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or estrogen receptor low (ER low) breast cancer who have not yet received treatment for their metastatic disease. You must be ineligible for anti-PD-1, anti-PD-L1, and hormone therapy. 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">Izalontamab brengitecan</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06926868' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bms.com/researchers-and-partners/in-the-pipeline.html' target='_blank'>Bristol Myers Squibb: Izalontamab brengitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></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: 341 miles
Cedars-Sinai Medical Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05318469

Ivermectin and Balstilimab Immunotherapy for Metastatic Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

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

VISITS: Every 3 weeks for 4.5 months

PHASE: II

NCT ID: NCT07017673

Ivonescimab Plus Carboplatin and Docetaxel Before Surgery for Stage I-III Triple Negative Breast Cancer

Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of adding ivonescimab, a bispecific antibody, to carboplatin and docetaxel chemotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive chemotherapy and an immune checkpoint inhibitor before surgery (neoadjuvant). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ivonescimab, by IV, every 3 weeks for 4.5 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 4.5 months</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks for 4.5 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</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">Ivonescimab is a bispecific antibody. It blocks the immune checkpoint molecule, PD-1, and a protein called VEGF that is needed for new blood vessel growth. The actions of this drug are expected to block tumor cell growth.</li> <li class="seamTextUnorderedListItem">Blocking immune checkpoint molecules with an immune checkpoint inhibitor may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Approved immune checkpoint inhibitors are pembrolizumab (Keytruda®) and dostarlimab-gxly (Jemperli®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07017673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.smmttx.com/ivonescimab-smt112/' target='_blank'>Summit Therapeutics: Ivonescimab</a> </li></ul>

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

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: 341 miles
Ellison Institute of Technology (EITM)
Los Angeles,CA

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

VISITS: 10 visits within 2 months

PHASE: II

NCT ID: NCT05491226

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 346 miles
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06926920

Sacituzumab Govitecan ADC at a Different Dose and Schedule in Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label Study of Sacituzumab Govitecan Administered at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a different dose and schedule of sacituzumab govitecan (Trodelvy), an 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 not yet received treatment for advanced disease. Your tumors must be PD-L1 negative, or you must have received treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq®) immunotherapy for early stage disease. You must not have received treatment with trastuzumab deruxtecan (Enhertu®) or sacituzumab govitecan (Trodelvy®) ADCs or irinotecan (Camptosar®) chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is FDA approved for advanced triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is studying a new way to give sacituzumab govitecan (Trodelvy®).</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 a chemotherapy drug to cancer cells with TROP2.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06926920' 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: 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: 348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles,CA

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06422455

Genetic Testing Education for People with Stage 0-IV Breast Cancer

Increasing Access to Genetic Testing in Underserved Patients Using a Multilingual Conversational Agent Scientific Title

Purpose

To gather feedback about genetic testing education with a computer-generated character as an alternative to standard of care genetic testing education with a human genetic counselor.

Who is this for?

People diagnosed with stage 0 (DCIS), stage I, stage II, stage III, or stage IV (metastatic) breast cancer before age 50, people with breast cancer in both breasts, people with triple negative (ER-, PR-, HER2-) breast cancer, or men with breast cancer. 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">Genetic testing education with PERLA, computer-generated character, 1 time before testing</li> <li class="seamTextUnorderedListItem">Genetic counseling with genetic counselor, 1 time after testing</li> <li class="seamTextUnorderedListItem">Interview</li> <li class="seamTextUnorderedListItem">Survey</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic testing education with genetic counselor, 1 time before testing</li> <li class="seamTextUnorderedListItem">Genetic counseling with genetic counselor, 1 time after testing</li> <li class="seamTextUnorderedListItem">Survey</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The computer-generated character in Group 1 is called a patient-facing relational agent (PERLA).</li> <li class="seamTextUnorderedListItem">Many people with cancer are recommended to receive genetic testing as standard of care.</li> <li class="seamTextUnorderedListItem">Lack of access to genetic counseling and testing is one reason people may not receive genetic testing.</li> <li class="seamTextUnorderedListItem">Education about genetic testing before recieving testing in both English and Spanish may lead to better access to genetic testing.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</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/NCT06422455' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07020117

225Ac-Ac-AKY-1189 Radioactive Drug for Advanced Triple Negative or HR+ Breast Cancer That is Nectin-4 Positive

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of 225Ac-Ac-AKY-1189, an experimental radioactive drug.

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+) breast cancer that is Nectin-4 positive. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">225Ac-Ac-AKY-1189, by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new type of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">225Ac-Ac-AKY-1189 is an experimental radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">225Ac-Ac-AKY-1189 targets Nectin-4 which is on some tumor 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/NCT07020117' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aktisoncology.com/our-science/' target='_blank'>Aktis Oncology: Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/mbc-radiopharmaceuticals/' target='_blank'>Metastatic Trial Talk: What Are Radiopharmaceuticals and How Are They Used in MBC?</a> </li></ul>

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

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: 353 miles
City of Hope National Medical Center /ID# 276272
Duarte,CA

VISITS: 2 years

PHASE: I

NCT ID: NCT05005403

Azirkitug Immunotherapy Alone or With Immunotherapy or Targeted Therapy for Advanced Triple Negative Breast Cancer

A Global First-in-Human Study in NSCLC, HNSCC and Solid Tumors With Azirkitug (ABBV-514) as a Single Agent and in Combination With Budigalimab or Bevacizumab Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of azirkitug, an experimental immunotherapy, alone or with budigalimab, an experimental immunotherapy, or bevacizumab (Avastin®) targeted therapy.

Who is this for?

People with some stage III (advanced) or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer. You must have received paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), or docetaxel (Taxotere®) chemotherapy for advanced disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azirkitug (ABBV-514), by IV</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azirkitug (ABBV-514), by IV</li> <li class="seamTextUnorderedListItem">Budigalimab, by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azirkitug (ABBV-514), by IV</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azirkitug (ABBV-514) and budigalimab are experimental immunotherapy drugs designed to increase the immune system's ability to find and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Budigalimab 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">Bevacizumab (Avastin®) is a targeted therapy that blocks the growth of new blood vessels, which tumors need to grow. It is approved for other cancers, and its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is 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/NCT05005403' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvieclinicaltrials.com/study/?id=M21-410' target='_blank'>Abbvie: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/science/pipeline.html#abbv-514' target='_blank'>Abbvie: Azirkitug Drug Information Page</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.abbvie.com/science/pipeline.html#abbv-181_(budigalimab)' target='_blank'>Abbvie: Budigalimab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.avastin.com/patient/mcrc/support/patient-resources.html' target='_blank'>Genentech: Bevacizumab (Avastin®)</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 2 visits every 3 weeks for 2 years

PHASE: I

NCT ID: NCT06908928

Bulumtatug Fuvedotin Antibody-Drug Conjugate for Advanced Triple-Negative Breast Cancer

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of bulumtatug fuvedotin 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 received no more than 3 lines of therapy. Past treatment must have included a taxane and certain antibody-drug conjugates. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin, by IV, weekly, 2 weeks on 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin is an antibody-drug conjugate that targets a protein called nectin-4 that is present on cancer cells.</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">Taxanes are paclitaxel (Taxol®) and docetaxel (Taxotere®).</li> <li class="seamTextUnorderedListItem">You must have received one of these antibody-drug conjugates: fam-trastuzumab deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), and datopotamab deruxtecan (Dato-DXd; Datroway®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06908928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mabwell.com/en/rd.html' target='_blank'>Mabwell: Bulumtatug Fuvedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>

NEAREST SITE: 374 miles
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange,CA

VISITS: Every 3 weeks for 4.5 months

PHASE: I-II

NCT ID: NCT07064018

Single Protein Encapsulated Doxorubicin (SPEDOX-6) Chemotherapy for Advanced Triple Negative Breast Cancer

Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of single protein encapsulated doxorubicin (SPEDOX-6) 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 at least 2 prior lines of therapy but not an anthracycline. 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">SPEEDOX-6, by IV, every 3 weeks for 4.5 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SPEEDOX-6, by IV, every 3 weeks for 4.5 months</li> <li class="seamTextUnorderedListItem">Filgrastim (Neupogen®) or pegfilgrastim (Neulasta®), by injection or IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SPEDOX-6 is a form of the chemotherapy medication doxorubicin that may cause less damage to the heart than traditional doxorubicin.</li> <li class="seamTextUnorderedListItem">Anthracyclines are doxorubicin (Doxil®), epirubicin (Ellence®), mitoxantrone (Novantrone®), and idarubicin (Idamycin®).</li> <li class="seamTextUnorderedListItem">Filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) are used to treat low white blood cell counts caused by some cancer medications.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07064018' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/resources-support/mbc-heart-problems/' target='_blank'>Metastatic Trial Talk: MBC Treatment-Related Heart Problems</a> </li></ul>

NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,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: 435 miles
Eisenhower Health
Rancho Mirage,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: 447 miles
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla,CA

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07190469

PQ203 Peptide Drug-Conjugate for Advanced Triple Negative Breast Cancer

A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PQ203 peptide drug-conjugate.

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">PQ203, by IV, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PQ203 is a peptide drug-conjugate, which is a type of therapy that combines a short protein that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is 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/NCT07190469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.proteinqure.com/science/' target='_blank'>Proteinqure: Peptide-Drug Conjugates</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
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: 650 miles
Mayo Clinic in Arizona
Phoenix,AZ

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>

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: 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 Hutchinson Cancer Center
Seattle,WA

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

VISITS: Every 1-3 weeks for 3 months, then every 6 months for up to 3 years

PHASE: II

NCT ID: NCT07078604

STEMVAC Vaccine in Combination With Chemo for Metastatic Triple-Negative Breast Cancer that is PD-L1 Negative

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, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of a vaccine called STEMVAC when it is given with standard chemotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer that is PD-L1 negative who have received no more than one line of therapy for metastatic disease. You must not have received immunotherapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STEMVAC vaccine with sargramostim, by injection, once a month for 3 months</li> <li class="seamTextUnorderedListItem">Standard chemotherapy chosen by your doctor</li> </ul> Followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 booster vaccines, by injection, 4 months and 7 months after the last treatment </li> <li class="seamTextUnorderedListItem">Ongoing booster vaccine, every 6 months, up to 3 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers want to learn if the vaccine helps the immune system recognize and attack breast cancer cells by targeting specific proteins found on the cancer cells.</li> <li class="seamTextUnorderedListItem">Standard chemotherapy options may include medicines such as paclitaxel, docetaxel, carboplatin, cisplatin, doxorubicin, liposomal doxorubicin, or eribulin.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07078604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: All About Vaccines for MBC</a> </li></ul>

NEAREST SITE: 734 miles
Summit Cancer Center
Spokane,WA

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>

NEAREST SITE: 941 miles
UCHealth University of Colorado Hospital
Aurora,CO

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: 948 miles
Dren Investigational Site
Denver,CO

VISITS: 1 visit every 2 weeks

PHASE: I

NCT ID: NCT06999187

DR-0202 Bispecific Antibody for Advanced Triple Negative or HR+ Breast Cancer

A Phase 1a/1b, Multicenter, Open-label, Dose Escalation/Expansion, Multiple-dose Study to Evaluate the Safety and Activity of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of DR-0202, an experimental bispecific antibody.

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+) breast cancer who have received at least 2 lines of therapy and have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DR-0202, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DR-0202 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two different targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06999187' target='_blank'>ClinicalTrials.gov</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.drenbio.com/pipeline.html' target='_blank'>Dren Bio: DR-0202 Drug Information Page</a> </li></ul>

NEAREST SITE: 951 miles
Normunity Investigational Site
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07182149

NRM-823 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of NRM-823 immunotherapy.

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">NRM-823</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NRM-823 is an immunotherapy drug that activates cells of the immune system to find and kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is 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/NCT07182149' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://normunity.com/pipeline/' target='_blank'>Normunity: NRM-823</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy/' target='_blank'>Metastatic Trial Talk: Immunotherapy</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: 1382 miles
Mercy Hospital - OKC
Oklahoma City,OK

VISITS: Coincides with biopsy

PHASE: NA

NCT ID: NCT07327489

Liver Biopsy to Predict Response to Immunotherapy for Metastatic Breast Cancer That has Spread to the Liver

Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies Scientific Title

Purpose

To collect liver tumor samples to study a possible response to immunotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has spread to the liver. You must have not yet started your next line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Liver biopsy as part of standard of care</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is collecting samples of breast cancer that has spread to the liver to understand ways to prepare the tissue to predict how a patient may respond to immunotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07327489' target='_blank'>ClinicalTrials.gov</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 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 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: 1479 miles
Mary Crowley Cancer Research
Dallas,TX

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: 1481 miles
Research Site
San Antonio,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT07115043

AZD6750 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of AZD6750 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 standard of care therapies. You must not have brain metastases that are untreated, unstable, or causing symptoms. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6750, by IV, up to 2 years</li> <li class="seamTextUnorderedListItem">Biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD6750 is an immunotherapy drug. Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">This trial is 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/NCT07115043' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1481 miles
The University of Texas Health Science Center at San Antonio
San Antonio,TX

VISITS: 1-5 visits every month

PHASE: I

NCT ID: NCT05029999

2 Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1481 miles
NEXT Oncology
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: 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: 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: 1643 miles
The University of Texas M. D. Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable, 1 year

PHASE: I

NCT ID: NCT06959537

Cyclophosphamide, Axatilimab, and Retifanlimab for Advanced Triple Negative or Inflammatory Breast Cancer

A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of cyclophosphamide (Cytoxan®) chemotherapy, axatilimab (Niktimvo®) targeted therapy, and retifanlimab (Zynyz®) immunotherapy.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by mouth</li> <li class="seamTextUnorderedListItem">Axatilimab (Niktimvo®), by IV</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Axatilimab (Niktimvo®) is used to treat rejection of transplanted cells and may have anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Retifanlimab (Zynyz®) is a PD-1 inhibitor. PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06959537' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.niktimvo.com/niktimvo-patient-information' target='_blank'>Incyte: Axatilimab (Niktimvo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zynyz.com/scac/?utm_source=google&utm_medium=psearch&utm_campaign=zyn-dtc-br-zynyz-phrase&utm_id=psearchrt9e&gad_source=1&gad_campaignid=22526170965&gbraid=0AAAAABZyZLqUc0VaUPDduSUyY43CjUMIU&gclid=Cj0KCQiAxJXJBhD_ARIsAH_JGjjIq6PGMymOkH7Wnw_GnH' target='_blank'>Incyte: Retifanlimab (Zynyz®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy/' target='_blank'>Metastatic Trial Talk: Immunotherapy</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
The University of Texas M. D. Anderson Cancer Center
Houston,TX

VISITS: 6 visits per month for 1 year

PHASE: I-II

NCT ID: NCT07011654

Naxitamab and Sacituzumab Govitecan for Metastatic Triple Negative Breast Cancer

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of naxitamab (Danyelza®) immunotherapy plus sacituzumab govitecan (Trodelvy®) antibody-drug conjugate.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received chemotherapy and/or are eligible to receive sacituzumab govitecan (Trodelvy®). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Naxitamab (Danyelza®), by IV, 3 times per week, 1 week on 2 weeks off</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). An 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">Naxitamab (Danyelza®) is a type of immunotherapy approved for children with neuroblastoma. 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/NCT07011654' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://danyelza.com/why-danyelza/' target='_blank'>Y-mAbs Therapeutics: Naxitamab (Danyelza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/patient/mtnbc' target='_blank'>Gilead Sciences: Sacituzumab govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-targeted-therapy/' target='_blank'>Metastatic Trial Talk: Targeted Therapy for Triple Negative MBC</a> </li></ul>

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

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: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks

PHASE: I

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 Mutated Breast Cancer with Brain Metastasis

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 niraparib (Zejula®) PARP inhibitor with dostarlimab (Jemperli®) PD-1 inhibitor.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with a BRCA1, BRCA2, ATM, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51, RAD51B, RAD51C, RAD51D, RAD52, or RAD54L mutation that has spread to the brain (brain metastasis). You must have received at least one line of therapy. 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> <li class="seamTextUnorderedListItem">Lumbar puncture (optional)</li> </ul> Please contact research site for treatment schedule
<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: I

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: 1664 miles
LSU Health Sciences Center
Shreveport,LA

VISITS: 1 visit

PHASE: I

NCT ID: NCT06700070

PBA-0111 Immunotherapy for Stage I-IV Triple Negative Breast Cancer

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PBA-0111 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 surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0111, by injection</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PBA-0111 targets a protein called GARP and may activate the immune system to kill tumor cells.</li> <li class="seamTextUnorderedListItem">PBA-0111 will be injected into the tumor using CIVO. CIVO is an experimental tool for injection of drug and fluorescent tracking microspheres called CIVO GLO that mark the sites of drug injection.</li> <li class="seamTextUnorderedListItem">This trial is 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/NCT06700070' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://purebiologics.com/news/pure-biologics-with-partnership-agreement-for-pb004-and-pb003g-projects/#:~:text=PBA%2D0111%20was%20developed%20by,to%20begin%20in%20early%202025.' target='_blank'>Pure Biologics: PBA-0111</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: 1832 miles
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee,WI

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02926690

OTS167PO: A Targeted Therapy for Advanced Triple Negative or ER-Low Breast Cancer

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer Scientific Title

Purpose

To determine the safety and effects (good and bad) of using the experimental targeted therapy OTS167PO.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OTS167PO </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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapy used in this trial is OTS167PO. It is a MELK inhibitor. </li> <li class="seamTextUnorderedListItem">It is an experimental therapy. This means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">Targets or mutations: MELK</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926690' 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.oncotherapy.co.jp/en/research-development/drug-discovery-research/melk-inhibitor/' target='_blank'>Drug Company Information Page: OTS167</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/melk-inhibitor-ots167' target='_blank'>NCI Drug Dictionary: OTS167</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: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: 2 visits every 3 weeks

PHASE: II

NCT ID: NCT04468061

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 1-2 visits every month

PHASE: II

NCT ID: NCT05846789

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: At least 3 visits within 5 months

PHASE: NA

NCT ID: NCT06744465

NearWave Imaging Device to Measure Treatment Response for Women with Stage II-III HER2+ or Triple Negative Breast Cancer

NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients Scientific Title

Purpose

To study the use of the NearWave imaging device to monitor tumors during treatment and predict treatment response.

Who is this for?

Women with newly diagnosed stage II or some stage III HER2 positive (HER2+) or triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive treatment before surgery (neoadjuvant). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NearWave optical molecular monitoring before, during, and after chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The NearWave system uses a non-invasive handheld imaging device.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06744465' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://nearwave.co/' target='_blank'>NearWave: Information Page</a> </li></ul>

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>

NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN

VISITS: Coincides with routine care

PHASE: II

NCT ID: NCT05770531

ctDNA Tests to Support Treatment Decisions for People with Metastatic Triple Negative, PD-L1 Negative Breast Cancer

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study how well circulating tumor DNA (ctDNA) tests work to support decisions to change treatment.

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Blood samples for ctDNA tests</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan, 2 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to sacituzumab govitecan (Trodelvy®), by IV (depending on blood test results)</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">Studying ctDNA may help your doctor decide to change your treatment earlier (if needed) and may improve your health outcomes.</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">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/NCT05770531' 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/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>

NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN

VISITS: Every 1-3 weeks for 6 months

PHASE: II

NCT ID: NCT07016399

Darolutamide With Standard Therapy or Standard Therapy Alone Before Surgery for Stage II-III Androgen Receptor Positive Triple Negative Breast Cancer

A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of darolutamide (Nubeqa®) androgen receptor inhibitor plus standard therapy versus standard therapy alone before surgery (neoadjuvant).

Who is this for?

People with newly diagnosed stage II or some stage III androgen receptor positive (AR+), triple negative (ER-, PR-, HER2-) breast cancer. 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 for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) or epirubicin (Ellence®), every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Ultrasound or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®), by mouth, for 2 weeks</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®), by mouth, for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) or epirubicin (Ellence®), every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Ultrasound or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®) is an androgen receptor inhibitor. It blocks the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide plus standard therapy before surgery (neoadjuvant) may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.</li> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®) is FDA approved to treat prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, AR positive is defined as ≥80% staining for AR by immunohistochemistry.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07016399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nubeqa-us.com/?utm_source=google&utm_medium=cpc&utm_campaign=NUB_DTC_cpc_google_BRN&utm_content=BRN_X_ALL_PHR_X_X&utm_term=darolutamide&gclsrc=aw.ds&gad_source=1&gad_campaignid=15641610910&gbraid=0AAAAACsxACzBEW_NkuB-pBDxOeDA5KvDu&gclid=Cj0KCQ' target='_blank'>Bayer: Darolutamide (Nubeqa®)</a> </li></ul>

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>

100

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>

101

NEAREST SITE: 2013 miles
UAB
Birmingham,AL

VISITS: 4 visits coinciding with 4 cycles of treatment

PHASE: I

NCT ID: NCT04861077

PET/MRI Scans to Predict Response to Immunotherapy in Triple Negative Breast Cancer

Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study Scientific Title

Purpose

To study if PET/MRI using a tracer called FMISO can help doctors see how well immunotherapy is working.

Who is this for?

Women with Stage II or Stage III or (metastatic) Stage IV, triple negative (ER-, PR-, HER2-) breast cancer planning to receive immunotherapy as part of their treatment. Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">This imaging trial will use a tracer called ¹⁸F-fluoromisonidazole (FMISO).</li> <li class="seamTextUnorderedListItem">FMISO PET/MRI works by giving a small injected tracer that sticks to certain parts of a tumor, letting doctors see those areas clearly on a combined PET and MRI scan.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04861077' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cedars-sinai.org/programs/imaging-center/exams/pet-ct-scans.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li></ul>

102

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>

103

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>

104

NEAREST SITE: 2135 miles
Emory Saint Joseph's Hospital
Atlanta,GA

VISITS: 3 visits in first 5 weeks, then 1 visit every 3 weeks for up to 7 months

PHASE: I

NCT ID: NCT06324240

Personalized TMV Vaccine With a Checkpoint Inhibitor for Stage I-IV Triple Negative Breast Cancer

Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study the safety, side effects (both good and bad), and possible anti-cancer activity of a personalized vaccine called the tumor membrane vesicle (TMV) vaccine, given with a checkpoint inhibitor, in people with triple-negative breast cancer.

Who is this for?

People with stage I, stage II, stage III, or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have completed surgery (for stage I-III), and have not received more than 3 lines of therapy for advanced disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: TMV vaccine and pembrolizumab <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TMV vaccine, by injection, at weeks 1, 3, and 5 </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4-7 months</li> </ul> Group 2: TMV vaccine and ipilimumab <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TMV vaccine, by injection, at weeks 1, 3, and 5</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, every 3 weeks for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The type of vaccine used in this trial is a personalized cancer vaccine called the tumor membrane vesicle (TMV) vaccine. It may help your immune system detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">The TMV vaccine is being studied alone and in combination with immunotherapy drugs like pembrolizumab and ipilimumab. </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">Ipilimumab (Yervoy®) is a type of immunotherapy called a CTLA-4 inhibitor, which is a type of immune checkpoint inhibitor. Blocking CTLA-4 may help the body’s immune system recognize and attack cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06324240' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy/' target='_blank'>Metastatic Trial Talk: What is Immunotherapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: All About Vaccines for MBC</a> </li></ul>

105

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>

106

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>

107

NEAREST SITE: 2139 miles
Emory University (Data Collection Only)
Atlanta,GA

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>

108

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>

109

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

VISITS: 1 visit every month

PHASE: II

NCT ID: NCT06434064

Tamoxifen Hormone Therapy and Liposomal Doxorubicin Chemotherapy for Advanced Triple Negative Breast Cancer

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of tamoxifen (Nolvadex®) hormone therapy with pegylated liposomal doxorubicin (Doxil®) chemotherapy.

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pegylated liposomal doxorubicin (Doxil®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Electrocardiogram (ECG)</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen which may help stop the growth of tumor cells that need estrogen to grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug that damages cancer cell DNA and blocks a protein (enzyme) needed for cancer cell division and DNA repair.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin is a form of the drug that is contained inside very tiny, fat-like particles.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. </li> <li class="seamTextUnorderedListItem">Giving tamoxifen and pegylated liposomal doxorubicin together may work better than giving either drug alone.</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">An electrocardiogram (ECG) is a way of recording the heart's electrical activity.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is 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/NCT06434064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/pegylated-liposomal-doxorubicin' target='_blank'>Cancer Research UK: Pegylated Liposomal Doxorubicin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

110

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>

111

NEAREST SITE: 2377 miles
Medical University of South Carolina
Charleston,SC

VISITS: weekly for up to 4.5 months

PHASE: II

NCT ID: NCT06845319

Carboplatin, Paclitaxel, and Pembrolizumab Before Surgery for Stage II-III Triple Negative Breast Cancer

Anthracycline-Free Neoadjuvant Chemoimmunotherapy for Triple Negative Breast Cancer Patients With Cardiomyopathy or at an Elevated Risk of Cardiotoxicity (NeoCARD): A Response Adapted Single-arm Phase 2 Trial Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of carboplatin (Paraplatin®) chemotherapy, paclitaxel (Taxol®) chemotherapy, and pembrolizumab (Keytruda®) immunotherapy before surgery (neoadjuvant).

Who is this for?

People with stage II or some stage III triple negative (ER-, PR-, HER2-) breast cancer who have not yet received chemotherapy, immunotherapy, radiation therapy, or surgery for this breast cancer and who cannot receive an anthracycline. People whose cancer is ER low or PR low (ER or PR expression between 1-10%) may participate. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for 3-4.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anthracyclines (doxorubicin (Doxil®), epirubicin (Ellence®), mitoxantrone (Novantrone®), and idarubicin (Idamycin®)) are commonly given to people with triple negative breast cancer. However, some people cannot receive these drugs because of heart problems.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a PD-1 inhibitor, which is a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and paclitaxel (Taxol®) may work together to make the immunotherapy drug pembrolizumab (Keytruda®) work better.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06845319' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?utm_source=google&utm_medium=cpc&utm_campaign=Keytruda+Pan+Tumor+KEYTRUDA+ONLY_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&utm_content=Brand+Keyword_General&utm_term=keytruda&gclid=Cj0KCQiAo4TKBhDRARIsAGW29bdlB02PnuvSg3Zw-PExGA63EXyer_4qUyoK' target='_blank'>Merck: Pembrolizumab (Keytruda®)</a> </li></ul>

112

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>

113

NEAREST SITE: 2382 miles
UNC Lineberger Comprehensive Cancer Center
Chapel Hill,NC

VISITS: 8 visits during treatment, then 1 visit every 3 months, up to 3 years

PHASE: II

NCT ID: NCT07069595

PREDICT-RD: Using ctDNA to Detect Triple Negative Breast Cancer After Surgery

PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease Scientific Title

Purpose

To use circulating tumor DNA (ctDNA) to detect cancer cells after surgery and to determine who will or will not receive benefit from Dato-DXd (a targeted therapy).

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 residual disease after neoadjuvant (before surgery) chemotherapy and surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) blood test at the time of surgery, every 6 weeks during treatment, then every 3 months, ongoing, up to 3 years</li> </ul> Positive ctDNA test at the time of surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, 8 times</li> </ul> Negative ctDNA test at the time of surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care adjuvant (after surgery) treatment</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</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">ctDNA tests are also called liquid biopsies.</li> <li class="seamTextUnorderedListItem">In this study, changes in ctDNA in the blood will be monitored during treatment, and for up to 3 years after completing treatment.</li> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an investigational antibody-drug conjugate (ADC) and a TROP2 (topoisomerase I) targeted therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07069595' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/liquid-biopsy/' target='_blank'>Metastatic Trial Talk: Understanding Liquid Biopsies for MBC</a> </li></ul>

114

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>

115

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 chemotherapy and/or radiation within the past 1.5 years. 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 surgery.</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>

116

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

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>

117

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 8 visits within 4 weeks

PHASE: I

NCT ID: NCT05504707

Dendritic Cell Vaccine for Stage I-III Triple Negative or HR Low, HER2- Breast Cancer

Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER) Scientific Title

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, 2 times per week for 4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">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/NCT05504707' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/for-healthcare-professionals/clinical-perspectives/clinical-perspectives-story-archive/cancer-immunotherapy-breakthrough-dendritic-cell-vaccines/' target='_blank'>Moffitt Cancer Center: What is a Dendritic Cell Vaccine?</a> </li></ul>

118

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>

119

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>

120

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT07067138

Set of Rules (Algorithm) to Find Therapeutic Options for Triple Negative or HR+, HER2- Metastatic Breast Cancer

An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast) Scientific Title

Purpose

To study whether a set of rules (an algorithm) called ENLIGHT can help choose approved drugs that will treat aggressive breast cancers more effectively.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received at least one line of therapy, be planning to stop your current therapy due to progression of your cancer or side effects, and be not eligible for another treatment. If HR+, your cancer must be resistant to hormone therapy. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">No therapy match, treatment selected by doctor</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">Treatment with matched, approved drug for participant's cancer, given by participant's doctor</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor analyzed by ENLIGHT, TruSight(R) Oncology 500, and TruSeq</li> <li class="seamTextUnorderedListItem">Treatment with matched drug approved for another use, given by doctors at NIH</li> <li class="seamTextUnorderedListItem">Blood samples</li> <li class="seamTextUnorderedListItem">Biopsy after treatment (optional)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized medicine currently selects only a small subgroup of patients by looking for direct matches between their cancer and treatments. This trial is testing a way of identifying more patients who may benefit from targeted therapies.</li> <li class="seamTextUnorderedListItem">ENLIGHT analyzes tumor tissue and may be useful for identifying therapeutic options for people with metastatic breast cancer who currently have limited treatment options.</li> <li class="seamTextUnorderedListItem">The TruSight and TruSeq tests look for biomarkers in tumor tissue and blood that match a person to an approved treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07067138' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/new-biomarkers/' target='_blank'>Metastatic Trial Talk: Biomarkers to Select Treatments for MBC</a> </li></ul>

121

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>

122

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>

123

NEAREST SITE: 2454 miles
United Theranostics
Glen Burnie,MD

VISITS: Every 1-3 weeks for up to 8 months

PHASE: I

NCT ID: NCT07311993

CLR 125 for Advanced Triple Negative Breast Cancer

A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of CLR 125 radiopharmaceutical.

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 one line of therapy. Full eligibility criteria

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You will receive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"> Small tracer dose for imaging (dosimetry)</li> </ul> After which you will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CLR 125, by IV, 4 times per 2-month cycle, for up to 8 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CLR 125, by IV, 4 times per 2-month cycle, for up to 6 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CLR 125, by IV, 4 times per 2-month cycle, for up to 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Small tracer dose for imaging (dosimetry) is to visualize tumors and understand how the drug distributes in the body</li> <li class="seamTextUnorderedListItem">CLR 125 delivers radiation to tumor cell DNA, killing the cancer cell. It is designed to minimize radiation exposure to normal tissues.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07311993' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cellectar.com/developmental-programs/auger-emitter' target='_blank'>Cellectar: CLR 125</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/mbc-radiopharmaceuticals/' target='_blank'>Metastatic Trial Talk: Radiopharmaceuticals</a> </li></ul>

124

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>

125

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>

126

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>

127

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>

128

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>

129

NEAREST SITE: 2568 miles
NYU Langone perimutter Cancer Center
New York,NY

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>

130

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>

131

NEAREST SITE: 2569 miles
Mount Sinai Health System
New York,NY

VISITS: 1 visit every week for 3 months

PHASE: I

NCT ID: NCT06637306

Dupilumab, Pembrolizumab, and Chemotherapy Before Surgery for Stage II-III Triple Negative Breast Cancer

Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of dupilumab (Dupixent®), an experimental immunotherapy, with pembrolizumab (Keytruda®) immunotherapy and paclitaxel (Taxol®) and carboplatin (Paraplatin®) chemotherapies before surgery (neoadjuvant).

Who is this for?

People with 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">Dupilumab (Dupixent®), by injection, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed 1 week later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, 1 time</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dupilumab (Dupixent®) is an immunotherapy drug approved for people with eczema, asthma, and other conditions. Its use in this trial is considered experimental.</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">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) 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/NCT06637306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/drugs/20590-dupilumab-injection' target='_blank'>Cleveland Clinic: Dupilumab (Dupixent®)</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/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/carboplatin' target='_blank'>Cancer Research UK: Carboplatin (Paraplatin®)</a> </li></ul>

132

NEAREST SITE: 2614 miles
Yale University
New Haven,CT

VISITS: 2 visits within 6 months

PHASE: NA

NCT ID: NCT07066189

Exercise and Nutrition to Improve Response to Chemotherapy and Immunotherapy Before Surgery for Women with Stage II-III Triple Negative Breast Cancer

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To study whether a nutrition and exercise program can improve pathologic complete response (pCR), meaning that no cancer is seen in the breast after chemotherapy.

Who is this for?

Women with stage II or stage III triple negative (ER-, PR-, HER2-) breast cancer who are planning to receive chemotherapy and immunotherapy before surgery (neoadjuvant). You must not have received more than one cycle of chemotherapy. You must not currently exercise more than 150 min/week or consume more than 7 fruits and vegetable/week. 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">Surveys</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Physical ability tests</li> <li class="seamTextUnorderedListItem">DEXA scan</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise counseling, virtual, 10 30-minute sessions weekly</li> <li class="seamTextUnorderedListItem">Surveys</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Physical ability tests</li> <li class="seamTextUnorderedListItem">DEXA scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise counseling will take place during the same time period you are receiving chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07066189' target='_blank'>ClinicalTrials.gov</a> </li></ul>

133

NEAREST SITE: 2615 miles
Yale University
New Haven,CT

VISITS: Every 1-2 weeks, up to 3 years

PHASE: I-II

NCT ID: NCT06963905

Sacituzumab Govitecan, Nivolumab, and Relatlimab for Advanced Triple Negative Breast Cancer

Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab govitecan (Trodelvy®) antibody-drug conjugate plus nivolumab (Opdivo®) immunotherapy compared to sacituzumab govitecan (Trodelvy®) plus nivolumab and relatlimab (Opdualag®) immunotherapy.

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 positive and who have received up to one line of chemotherapy with pembrolizumab (Keytruda®). 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, weekly, 2 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Nivolumab and relatlimab (Opdualag®), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06963905' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdualag.com/' target='_blank'>Bristol-Myers Squibb: Nivolumab and Relatlimab (Opdualag®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivohcp.com/moa?cid=sem_3106674&gclsrc=aw.ds&gad_source=1&gad_campaignid=20368499447&gbraid=0AAAAAC8A2swePAj7GyEHocSxH3Q_4Jt4i&gclid=CjwKCAiA0eTJBhBaEiwA-Pa-heT3oAEuMQkKegBYuKvzGVyJp7S3bkugMz3e-hvXi0fkTK7GWepqchoCuTUQAvD_BwE' target='_blank'>Bristol-Myers Squibb: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/patient/mtnbc?utm_source=google&utm_medium=cpc&utm_campaign=us_sem_trmd_onc_dtp_ex_mtnbc_go_na_na_b_standard_branded_1432nn&utm_content=17054576844%3B136230621779%3Bkwd-946345024054&utm_term=trodelvy&gclsrc=aw.ds&gad_source=1&gad_' target='_blank'>Gilead Sciences: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy/' target='_blank'>Metastatic Trial Talk: Immunotherapy</a> </li></ul>

134

NEAREST SITE: 2684 miles
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence,RI

VISITS: Every 3 weeks

PHASE: II

NCT ID: NCT06974604

Preventing Mouth Sores Due to Dato-DXd With Dexamethasone Mouthwash for Advanced HR+, HER2- or Triple Negative Breast Cancer

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087) Scientific Title

Purpose

To study if a dexamethasone mouthwash can prevent mouth sores following treatment with datopotamab deruxtecan (Dato-DXd; Datroway®).

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 at least one line of therapy OR people with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed on hormone therapy and a CDK 4/6 inhibitor and 1 prior line of chemotherapy and/or antibody-drug conjugate (ADC). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd; Datroway®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 5 days per week for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd; Datroway®) is an antibody-drug conjugate (ADC), which 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">A common side effect of datopotamab deruxtecan (Dato-DXd; Datroway®) is mouth sores and inflammation of the inside of the mouth, called stomatitis.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06974604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/digestive-system/?utm_medium=email&utm_source=subscribers&utm_campaign=Dec2024&utm_content=Email122024' target='_blank'>Metastatic Trial Talk: Managing Side Effects of Treatment: Digestive System Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://datroway.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22411693368&gbraid=0AAAAA-nL_-d3XIFfFFEx4zohhCrXvhfIZ&gclid=Cj0KCQiAjJTKBhCjARIsAIMC4481LG5Jq8xB9UdmzCJ1we3heac32-SwjTGI7Na6ktS2O8VU50e0DxoaAjnfEALw_wcB' target='_blank'>Daiichi Sankyo: Datopotamab Deruxtecan (Dato-DXd; Datroway®)</a> </li></ul>

135

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>

136

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 Breast Cancer <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>

137

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT06610097

Studying the Gut Microbiome During Neoadjuvant Treatment for Stage I-III Triple Negative Breast Cancer

Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer Scientific Title

Purpose

To study changes in the gut microbiome during neoadjuvant (before surgery) treatment for triple negative breast cancer.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer. You must not be receiving before surgery (neoadjuvant) treatment or prebiotics or probiotics. 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">Nutrition counseling, virtual, 3 sessions</li> <li class="seamTextUnorderedListItem">Surveys, 4 times in 6 months</li> <li class="seamTextUnorderedListItem">Stool (poop) samples, 4 times in 6 months</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational handout</li> <li class="seamTextUnorderedListItem">Surveys, 4 times in 6 months</li> <li class="seamTextUnorderedListItem">Stool (poop) samples, 4 times in 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The gut microbiome is made up of bacteria, viruses, and other organisms that live in the digestive tract and help keep us healthy. </li> <li class="seamTextUnorderedListItem">The gut microbiome changes in response to treatments for triple negative breast cancer, and this may lead to worse outcomes. </li> <li class="seamTextUnorderedListItem">The gut microbiome can be changed by changing the diet.</li> <li class="seamTextUnorderedListItem">To encourage participation and retention, you will be given a $40 gift certificate per stool sample with up to $200 total compensation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06610097' target='_blank'>ClinicalTrials.gov</a> </li></ul>

138

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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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>