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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: August 15, 2026)

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AKT

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RAF (including BRAF)

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ROS1

TP53

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-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: 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 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 Medical Center
Sacramento,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05208762

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-PDL1V is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Its antibody targets PD-1/PD-L1, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called vedotin.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05208762' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrials.seagen.com/study/?pid=SGNPDL1V-001' target='_blank'>Seagen Trial Information Page: SGN-PDL1V</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.seagen.com/press-releases/news-details/2021/Seagen-to-Highlight-Two-Novel-Antibody-Drug-Conjugates-ADCs-at-the-SITC-36th-Annual-Meeting/default.aspx' target='_blank'>Seagen Press Release: SGN-PDL1V</a> </li></ul>

NEAREST SITE: 74 miles
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: 186 miles
Renown Regional Medical Center
Reno,NV

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: 336 miles
UCLA Department of Medicine - Hematology/Oncology
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: 339 miles
Start Lacn
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07517198

EXS74539 Targeted Therapy for Advanced Triple Negative Breast Cancer

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of EXS74539 (also called REC‑4539), an experimental targeted therapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer, that has progressed after at least one previous therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EXS74539, by mouth, daily</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EXS74539 (also called REC‑4539) is an experimental targeted cancer drug that works as an LSD1 inhibitor.</li> <li class="seamTextUnorderedListItem">An LSD1 inhibitor is a new type of drug that tries to slow or stop cancer by blocking a protein that helps cancer cells grow and resist treatment.</li> <li class="seamTextUnorderedListItem">This study is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07517198' target='_blank'>ClinicalTrials.gov</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 Department of Medicine-Hematology/Oncology
Los Angeles,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: 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: 339 miles
USA06-0
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT06953089

Antibody-Drug Conjugate and Immunotherapy for Advanced Breast Cancer

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety and anti-cancer activity of DB-1311 (a targeted therapy called an antibody-drug conjugate, or ADC) combined with either BNT327 (pumitamig, an immunotherapy) or DB-1305 (another ADC), in people with advanced or metastatic breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is triple negative (ER-, PR-, HER2-), OR hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER2 low, or HER2 ultralow whose cancer has progressed after receiving standard treatment. This trial is also enrolling people with other types of cancer. Full eligibility criteria

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You will be assigned to one of two groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1311, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">BNT327 (pumitamig), by IV, every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1311, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">DB-1305, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DB-1311 is an antibody-drug conjugate (ADC). It attaches to a protein called B7-H3 found on the surface of many cancer cells, and delivers a cell-killing drug directly into those cells, while sparing healthy tissue.</li> <li class="seamTextUnorderedListItem">BNT327 (pumitamig) is an immunotherapy. It works by blocking two targets at once: PD-L1 (a protein that helps cancer hide from the immune system) and VEGF-A (a protein that helps tumors grow new blood vessels). By blocking both, it may help the immune system recognize and attack cancer cells more effectively.</li> <li class="seamTextUnorderedListItem">DB-1305 is also an antibody-drug conjugate, similar in design to DB-1311, but targets a different protein called TROP2, which is found on the surface of many breast cancer cells.</li> <li class="seamTextUnorderedListItem">Researchers want to learn whether combining these drugs leads to better results than using them alone, and which combination is most effective and best tolerated.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06953089' target='_blank'>ClinicalTrials.gov</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: 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: 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: May require hospitalization

PHASE: I

NCT ID: NCT05989828

TCR T Cell Therapy for Women with Advanced Triple Negative, HLA-A2+ Breast Cancer That Overexpresses NY-ESO-1

Phase Ib Clinical Trial of Autologous Anti-NY-ESO-1 TCR-Engineered T Cells in Patients With Relapsed/Refractory Locally Advanced or Metastatic NY-ESO-1-Expressing Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of an experimental T cell immunotherapy using a person's own modified immune cells.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low), HLA-A2 positive (HLA-A2+) breast cancer that overexpresses NY-ESO-1 who have received 2-3 lines of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> followed 1 month later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 times</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TCR T cell therapy, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Aldesleukin (Proleukin®), by IV, 3 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT scans</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NY-ESO-1 is a protein found on the surface of many different types of tumor cells including triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect immune cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">Immune cells obtained with leukapheresis can be trained to recognize NY-ESO-1 on tumor cells, allowing the immune cells to attack and kill those tumor cells.</li> <li class="seamTextUnorderedListItem">In this study, immune cells are removed from your blood, taught how to recognize and kill tumor cells, and then injected back into your body. This is a type of T cell receptor (TCR) immunotherapy.</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 (Proleukin®) stimulates the body to produce other chemicals that increase the body's ability to fight cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05989828' 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: 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 /ID# 279603
Los Angeles,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: 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
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: 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: 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: 595 miles
START Mountain Region, LLC
West Valley City,UT

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07503808

IDE034 Antibody-Drug Conjugate for Advanced Triple Negative Breast Cancer

An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of IDE034, 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 whose cancer cells have the B7‑H3 and PTK7 proteins, and who have received at least 1 line of therapy for advanced disease or 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">IDE034</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. 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"> IDE034 is an experimental ADC. It uses an antibody to deliver chemotherapy directly into cancer cells that carry the B7‑H3 and PTK7 proteins.</li> <li class="seamTextUnorderedListItem">B7‑H3 and PTK7 are proteins that can be found on the surface of some 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/NCT07503808' 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: 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 Dallas
Irving,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07578571

IM-1617 for Advanced Triple Negative or Hormone Receptor Positive, HER2-Negative Breast Cancer

A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of IM-1617, an antibody-drug conjugate.

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. You must have progressed on, been unable to tolerate, or had a contraindication to standard treatments, with no satisfactory standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IM-1617, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IM-1617 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">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/NCT07578571' 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: 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: 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: 1481 miles
NEXT Oncology - PARENT
San Antonio,TX

VISITS: 1 visit every 3 weeks, up to 2 years

PHASE: I

NCT ID: NCT07360314

M7437 Antibody-Drug Conjugate for Triple Negative Advanced Breast Cancer

A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of M7437, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer triple negative (ER-, PR-, HER2-) breast cancer. You must have received at least one line of therapy and have no standard treatment options available. Full eligibility criteria

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<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> <li class="seamTextUnorderedListItem">The drug being studied (M7437) is designed to target cancer cells that have Ly6E on them.</li> <li class="seamTextUnorderedListItem">High levels of Ly6E have been linked to cancer growth and spread, resistance to some treatments and the cancer’s ability to hide from the immune system.</li> <li class="seamTextUnorderedListItem">This trial also includes people with other types of advanced cancers that have high Ly6E expression.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07360314' 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: 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
Dallas,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: 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
Rochester,MN

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>

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
UT MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05111561

ZEN003694 and Binimetinib Targeted Therapy for Advanced Breast Cancer With a RAS Mutation or Triple Negative Breast Cancer

A Phase 1 Study of ZEN003694 in Combination With Binimetinib in Solid Tumors With RAS Pathway Alterations and 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 targeted therapy called a BET inhibitor, and binimetinib (Mektovi®), a targeted therapy called a MEK inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a RAS mutation or triple negative (ER-, PR-, HER2-) breast cancer that has progressed on standard treatment. You must not have a PIK3CA mutation or have received treatment with a BET, RAF, MEK, or ERK inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694, by mouth, daily</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®), by mouth, daily</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN-3694 is an experimental type of targeted therapy called a BET inhibitor.</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is a type of targeted therapy called a MEK inhibitor. It is approved for other types of cancer.</li> <li class="seamTextUnorderedListItem">Blocking BET and MEK may help slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: RAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05111561' 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.mayoclinic.org/drugs-supplements/binimetinib-oral-route/side-effects/drg-20443876?p=1' target='_blank'>Mayo Clinic: Binimetinib (Mektovi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</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
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: 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: 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: 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: 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: 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>

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

VISITS: At least 2 visits over 6-8 weeks

PHASE: NA

NCT ID: NCT05037825

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 2013 miles
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>

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>

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>

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>

NEAREST SITE: 2139 miles
Emory University Hospital
Atlanta,GA

VISITS: About 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05741164

Propranolol and Pembrolizumab for Women with Advanced Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">Questionaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Propranolol is a beta blocker drug used to treat high blood pressure and heart problems.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Beta blockers, including propranolol, may reduce the effects of some stress hormones produced by the body during cancer treatment. This process may help pembrolizumab (Keytruda®) work better.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05741164' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: Up to 2-4 vistis per month, follow up visits every 3 months

PHASE: II

NCT ID: NCT06492759

Radiation with Pembrolizumab and Chemotherapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer

A Phase II Study of High Dose Radiotherapy in Combination With Pembrolizumab Plus Chemotherapy in Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), side effects and anti-cancer activity of radiation combined with an immunotherapy, pembrolizumab (Keytruda®) and chemotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD‑L1 positive who have not yet received chemotherapy for metastatic disease. The cancer must have spread to at least two places in your body, with at least one site that can be treated with radiation. Full eligibility criteria

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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. </li> <li class="seamTextUnorderedListItem">Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.</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">Researchers are studying whether giving targeted radiation just before and during the first cycle of immunotherapy and chemotherapy can help control 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/NCT06492759' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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>

NEAREST SITE: 2264 miles
UPMC Magee Womens Hospital
Pittsburgh,PA

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT06833853

CTC‑EXPRESS: Using Blood Tests to Help Guide Treatment and Monitoring in Advanced Breast Cancer

CTC-EXPRESS: A Prospective Observational Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Scientific Title

Purpose

To find out whether special blood tests, that look for cancer cells and cancer‑related genetic material circulating in the blood, can help doctors make better decisions about breast cancer treatment and monitoring.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HR+/HER2- breast cancer before starting first line of treatment or triple negative breast cancer who are starting any line of treatment, or HER2+ breast cancer after receiving first line of treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, taken during routine appointments</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are studying special blood tests that look for cancer cells and cancer‑related genetic material circulating in the blood. These test results help doctors choose treatments, understand how well treatment is working, and track whether the cancer is changing or progressing.</li> <li class="seamTextUnorderedListItem">Advanced blood tests can count cancer cells (CTC enumeration), check cancer markers on those cells (CTC expression), and look for cancer‑related DNA and RNA floating in the blood (cfDNA/RNA).</li> <li class="seamTextUnorderedListItem">When you can join depends on the type of breast cancer you have: HR+/HER2‑ breast cancer before starting first‑line treatment; Triple negative breast cancer starting any line of treatment, and HER2‑positive breast cancer starting second‑line treatment or later</li> <li class="seamTextUnorderedListItem">This is an observational study, and no experimental drugs are given as part of the study.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06833853' 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>

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>

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>

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>

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>

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>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: up to 4 years

PHASE: III

NCT ID: NCT07357298

Scheduled Brain MRI Scans to Find Brain Metastases Early in Stage IV Breast Cancer

Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer Scientific Title

Purpose

This trial is studying whether getting a brain MRI every 6 months (before any symptoms appear) can find brain metastases earlier than standard care, which only orders a brain scan if symptoms develop.

Who is this for?

People with metastatic (stage IV) breast cancer of any subtype: hormone receptor positive (ER+ and/or PR+), HER2 positive, or triple negative (ER-, PR-, HER2-). You must join within 60 days of your stage IV diagnosis or within 60 days of starting your first treatment for stage IV disease. You must not have been previously diagnosed with brain metastases or leptomeningeal disease, and you must not currently have neurologic symptoms that would already call for a brain MRI. 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">Brain MRI scan at the start of the study, then every 6 months for 2 years (about 5 scans total).</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan at the start of the study. After that, you will only have a brain scan if you develop neurologic symptoms.</li> <li class="seamTextUnorderedListItem">Please contact research site for treatment schedule.</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">This trial is studying whether looking for brain metastases early leads to better outcomes than the usual approach of scanning the brain only when symptoms appear. </li> <li class="seamTextUnorderedListItem">Both groups get a brain MRI at the start of this study. The trial team will then compare the two groups to see whether earlier detection changes the type of treatment given for brain metastases (such as surgery or whole-brain radiation), how many and how large the metastases are, whether leptomeningeal disease (cancer spread to the fluid and tissue around the brain and spinal cord) is found more often, and whether there are differences in quality of life and survival.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07357298' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: Every 1-2 weeks

PHASE: II

NCT ID: NCT07694986

Dendritic Cell Vaccine Immunotherapy for Metastatic Breast Cancer With Leptomeningeal Disease

Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD) Scientific Title

Purpose

To study the effects (good and bad), and anti-cancer activity of a dendritic cell vaccine combined with either trastuzumab (Herceptin®) or nivolumab (Opdivo®), depending on HER2 status.

Who is this for?

People with with metastatic (stage IV) HER2 positive or HER2 negative (hormone receptor-positive or triple negative) breast cancer that has spread into the fluid surrounding the brain and spinal cord, a condition called leptomeningeal disease (LMD). You must have received have received radiation to the whole brain. You have (or can have) an Ommaya reservoir (a small device placed under the scalp that allows treatment to reach the fluid around your brain and spinal cord). You must be able to receive care at Moffitt Cancer Center in Tampa, Florida, as this trial is only offered at this location. Full eligibility criteria

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You will receive the following based on whether your cancer is HER2-positive or HER2-negative: Group 1 (HER2-negative) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine (cDC1), given directly into the fluid around the brain and spinal cord through your Ommaya reservoir</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), 50 mg, given the same way, every 2 weeks</li> </ul> Group 2 (HER2-positive) <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine (cDC1), given directly into the fluid around the brain and spinal cord through your Ommaya reservoir</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), 150 mg, given the same way, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this trial, instead of IV or pill form, treatment is delivered directly into the fluid around the brain and spinal cord through an Ommaya reservoir. </li> <li class="seamTextUnorderedListItem">An Ommaya reservoir is a small device placed under the scalp that allows treatment to reach the fluid around your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">Researchers are testing a dendritic cell vaccine, an immunotherapy designed to teach the immune system to recognize and attack breast cancer cells. </li> <li class="seamTextUnorderedListItem">Trastuzumab is a targeted therapy that blocks the HER2 protein on cancer cells for HER2-positive disease.</li> <li class="seamTextUnorderedListItem"> Nivolumab is an immunotherapy that helps immune cells attack cancer for HER2-negative disease.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07694986' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/for-healthcare-professionals/clinical-perspectives/clinical-perspectives-story-archive/now-enrolling--novel-dendritic-cell-vaccines-immunotherapy-trial-for-her2-breast-cancer/' target='_blank'>Moffitt Cancer Center: Novel Dendritic Cell Vaccines Immunotherapy Trial For HER2+ Breast Cancer</a> </li></ul>

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>

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>

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>

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>

NEAREST SITE: 2548 miles
Rutgers Cancer Institute
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>

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>

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>

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>

100

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>