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Find Breast Cancer Clinical Trials That Are Right For You

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

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

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(Last updated: May 24, 2025)

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AKT

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TP53

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05812807

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

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

Purpose

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

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have no residual disease after neoadjuvant (before surgery) chemotherapy and pembolizumab (Keytruda®) and negative margins after surgery. You must have received surgery less than 3 months ago. Full eligibility criteria

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

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05929768

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

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

Purpose

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

Who is this for?

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

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

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

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

PHASE: III

NCT ID: NCT05633654

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

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

Purpose

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

Who is this for?

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

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

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

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

PHASE: III

NCT ID: NCT06393374

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

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

Purpose

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

Who is this for?

People with stage I, stage II, and stage III triple negative (ER-, PR-, HER2-) breast cancer who received neoadjuvant (before surgery) pembrolizumab (Keytruda®) with chemotherapy and surgery. You must have cancer cells remaining (non-pathologic complete response) after surgery less than 3 months ago. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months for 6 months</li> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (sac-TMT), by IV, every 2 weeks for 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab tirumotecan targets TROP2 proteins. It delivers the chemotherapy belotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Non-pathologic complete response is the presence of cancer cells after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06393374' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Sacituzumab Tirumotecan Drug Information Page</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Stanford,CA

VISITS: 2 visits within 6 months

PHASE: II

NCT ID: NCT04768426

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

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

Purpose

To use circulating tumor DNA (ctDNA) to identify who will or will not experience benefit from adjuvant (after surgery) capecitabine (Xeloda®) chemotherapy.

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have residual disease after neoadjuvant (before surgery) chemotherapy and surgery. You must be planning to receive capecitabine (Xeloda®) after surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> <li class="seamTextUnorderedListItem">Blood test, 2 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">ctDNA tests are also called liquid biopsies.</li> <li class="seamTextUnorderedListItem">In this study, changes in ctDNA in the blood will be monitored over time during capecitabine (Xeloda®) treatment and related to genetic mutations in tumors. </li> <li class="seamTextUnorderedListItem">Results from this study may provide information for future clinical trials in which patients receive a different treatment than capecitabine (Xeloda®) to reduce their risk of breast cancer coming back (recurrence).</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04768426' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 250 miles
Research Site
Bakersfield,CA

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

PHASE: III

NCT ID: NCT06112379

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

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

Purpose

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

Who is this for?

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

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd), by IV, every 3 weeks, for 6 months before surgery</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, for 6 months before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, before surgery</li> <li class="seamTextUnorderedListItem">Chemotherapy, before surgery</li> </ul> followed by (after surgery): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 7 months</li> <li class="seamTextUnorderedListItem">Chemotherapy (if residual disease is found)</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth (if applicable)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab deruxtecan (Dato-DXd) is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) combines an antibody that targets cancer cells with a therapy that kills cancer cells.</li> <li class="seamTextUnorderedListItem">Because it only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Dato-DXd's antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are types of immunotherapy called PD-L1 inhibitors, which are a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a targeted therapy called a PARP inhibitor, which work by blocking the action of an enzyme that helps repair DNA. It will be given to people with residual disease and BRCA positive (BRCA+) tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html#oncology' target='_blank'>AstraZeneca: Datopotamab Deruxtecan (Dato-DXd) Drug Information Page</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04333706

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 2 visits within 1.5 months

PHASE: NA

NCT ID: NCT03463954

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Novilase® laser ablation</li> </ul> followed 1-1.5 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Novilase® laser ablation system kills tumor cells by heating the tissue with a laser.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03463954' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://novilase.com/' target='_blank'>Novian Health: Novilase®</a> </li></ul>

NEAREST SITE: 496 miles
Oregon Oncology Specialists
Salem,OR

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06230185

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

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

Purpose

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

Who is this for?

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

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You will provide the following for ctDNA and genomic testing: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples, before and during treatment</li> <li class="seamTextUnorderedListItem">Tumor samples, during surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">ctDNA can be detected in blood with a <q>liquid biopsy</q>.</li> <li class="seamTextUnorderedListItem">The absence of ctDNA is associated with a pathological complete response (no signs of cancer).</li> <li class="seamTextUnorderedListItem">Detection of ctDNA is associated with cancer recurrence (cancer coming back).</li> <li class="seamTextUnorderedListItem">Pathological complete response (pCR) means there are no signs of cancer in tissue samples removed during surgery after neoadjuvant (before surgery) treatment.</li> <li class="seamTextUnorderedListItem">Information from this study will be used to improve the detection of ctDNA for future patients.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06230185' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

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

PHASE: II

NCT ID: NCT06353997

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INBRX-106, by IV, every 3 weeks for 4-5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 4-5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INBRX-106 is an experimental immunotherapy that may help stimulate T cells to identify and attack cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">The combination of INBRX-106 and pembrolizumab (Keytruda®) may be used before surgery (neoadjuvant) instead of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06353997' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://inhibrx.com/inbrx-106/' target='_blank'>Inhibrx Biosciences: INBRX-106 Drug Information Page</a> </li></ul>

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

VISITS: Coincides with surgery

PHASE: II

NCT ID: NCT05464082

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

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

Purpose

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

Who is this for?

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

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Precision oncology is treatment based on specific information from your tumor.</li> <li class="seamTextUnorderedListItem">The tumor samples will be used to complete tests to determine which treatments may be most effective.</li> <li class="seamTextUnorderedListItem">If your cancer comes back (recurrence) after surgery and chemotherapy, your doctor will receive information to help make treatment decisions.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">In this trial, hormone receptor (HR) low is defined as 1-10% of cells that are ER+ and PR+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05464082' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: What is Precision Oncology?</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03979508

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

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

Purpose

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

Who is this for?

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

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, for 2 to 3 weeks</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low, HER2- breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor approved to treat HR+ and HER2- metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03979508' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: What Are CDK4/6 Inhibitors?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/?utm_source=google&utm_medium=ppc&campaign=6456675261&adgroup=82640243172&ad=378689406892&utm_keyword=kwd-389189556877&gclid=Cj0KCQiAmsrxBRDaARIsANyiD1qSisgRZtObbCNg3aCVnfoCwqXFjJlXYQsig6GLWR1OKy3oM7jjYJIaAtcqEALw_wcB' target='_blank'>Eli Lilly and Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/09/01/mbc-news-3/' target='_blank'>Metastatic Trial Talk: Insights Into Treatment Resistance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6523967/' target='_blank'>Journal Article: Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer</a> </li></ul>

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

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

PHASE: II

NCT ID: NCT05455658

STEMVAC Vaccine for Stage I-III Triple Negative Breast Cancer

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

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

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

Purpose

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

Who is this for?

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

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This is a data collection (registry) study. You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>

NEAREST SITE: 1387 miles
Oklahoma Univeristy
Oklahoma City,OK

VISITS: 1-3 visits every month

PHASE: I

NCT ID: NCT06136884

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AO-252, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AO-252 is an experimental targeted therapy called a TACC3 inhibitor. TACC3 inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06136884' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.a2apharma.com/copy-of-pipeline-1' target='_blank'>A2A Pharmaceuticals: AO-252 Drug Information Page</a> </li></ul>

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

VISITS: 3 visits within 1 month

PHASE: I

NCT ID: NCT06246786

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06008275

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a type of anti-HER2 targeted therapy called an EGFR inhibitor. It blocks EGFR which slows or stops cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is an experimental targeted therapy called a JAK/STAT3 inhibitor. It may block JAK/STAT3 which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is approved for use in other cancers. Its use in this trial is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06008275' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-targeted-therapy/' target='_blank'>Metastatic Trial Talk: Triple-Negative Metastatic Breast Cancer: Beyond ER, PR, and HER2</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-resistance/' target='_blank'>Metastatic Trial Talk: Discovering New Ways to Overcome Treatment Resistance in Triple-Negative MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/jakafi' target='_blank'>National Cancer Institute: Ruxolitinib (Jakafi®)</a> </li></ul>

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

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

PHASE: II

NCT ID: NCT05645380

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable, over 2 months

PHASE: II

NCT ID: NCT03546686

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Weekly study visits during radiation treatment

PHASE: NA

NCT ID: NCT02945579

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An image-guided biopsy (a biopsy that uses imaging such as CT, ultrasound, MRI or mammography)</li> <li class="seamTextUnorderedListItem">If the biopsy does not show any evidence of disease, you will then have radiation therapy</li> <li class="seamTextUnorderedListItem">If the biopsy show evidence of disease, you will have surgery then radiation therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink tumors before surgery. The tumor may even disappear. When this occurs, researchers think it may be possible for patients to avoid surgery.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02945579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

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

VISITS: Coincides with routine care

PHASE: NA

NCT ID: NCT02276443

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

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

Purpose

To study if tumor testing before treatment improves treatment response.

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarker and molecular tumor testing</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Ultrasound, 4 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your choice of standard of care treatment or clinical trial based on testing results</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like chemotherapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Studies suggest molecular testing of tumors can help guide treatment options.</li> <li class="seamTextUnorderedListItem">This study will compare tumor response of women whose treatment is guided by tumor testing results to those of women whose treatment is chosen without tumor testing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02276443' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2014-0185.html' target='_blank'>MD Anderson Cancer Center: ARTEMIS Trial Information Page</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06318897

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> </ul> You will then be assigned to 1 of 2 groups based on your response to treatment: Group 1: No Cancer Detected After Neoadjuvant Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Group 2: Cancer Detected After Neoadjuvant Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxin®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), doxorubicin (Doxil®), and cyclophosphamide (Cytoxin®) are chemotherapy drugs.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06318897' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT05675579

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1644 miles
Harris Health System - Smith Clinic
Houston,TX

VISITS: Coincides with routine care

PHASE: II

NCT ID: NCT05020860

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

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

Purpose

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

Who is this for?

People with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+); HER2 positive (HER2+); or triple negative (ER-, PR-, HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment based on tumor type</li> <li class="seamTextUnorderedListItem">ctDNA tests</li> <li class="seamTextUnorderedListItem">MRI scan, 2 times (for people with triple negative breast cancer)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A pathologic complete response (pCR) means that there are no cancer cells identified in the tissue removed at surgery.</li> <li class="seamTextUnorderedListItem">All treatment in this study is standard of care.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) is DNA from a tumor circulating in the bloodstream.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05020860' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pathologic-complete-response' target='_blank'>National Cancer Institute: Pathologic Complete Response</a> </li></ul>

NEAREST SITE: 1845 miles
Loyola University Chicago
Maywood,IL

VISITS: 3 visits over 2 months

PHASE: I

NCT ID: NCT02977468

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT06318507

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1853 miles
University of Illinois
Chicago,IL

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

PHASE: I

NCT ID: NCT04427293

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

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

Purpose

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

Who is this for?

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

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

NEAREST SITE: 1853 miles
Rush University Medical Center
Chicago,IL

VISITS: 2 visits within 1-2 weeks

PHASE: I

NCT ID: NCT06229392

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: At least 3 visits within 5 months

PHASE: NA

NCT ID: NCT06744465

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 2 visits in 2.5 months

PHASE: NA

NCT ID: NCT05677802

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Number of visits unavailable

PHASE: NA

NCT ID: NCT05877859

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

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

Purpose

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

Who is this for?

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

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

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

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

PHASE: II

NCT ID: NCT04677816

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

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

Purpose

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

Who is this for?

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

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You will be assigned to 1 of 2 groups: Group 1: Experimental for People With Vitamin D Deficiency <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li> <li class="seamTextUnorderedListItem">Vitamin D3, by mouth, weekly for 5 months</li> <li class="seamTextUnorderedListItem">Drug diary</li> </ul> Group 2: Standard of Care for People Without Vitamin D Deficiency <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), every 2-3 weeks for up to 5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), weekly for up to 5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®), and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies. </li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04677816' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/diet-nutrition/dietary-supplements/known/vitamin-d' target='_blank'>Breastcancer.org: Vitamin D and Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/integrative-medicine/herbs/vitamin-d#:~:text=A%20meta%2Danalysis%20of%20vitamin,supportive%20hazard%20ratio%20(90).' target='_blank'>Mayo Clinic: Vitamin D</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

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

VISITS: 5 doses per week for 3-6 weeks

PHASE: II

NCT ID: NCT05528133

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

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

Purpose

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

Who is this for?

People with stage I, stage II, or stage III triple negative (ER-, PR-, HER2-) breast cancer who have received a lumpectomy and lymph node biopsy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation based on radiosensitivity index, 5 doses per week for 3-6 weeks</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation, 5 doses per week for 4-6 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">The radiosensitivity index is a test that evaluates 10 genes to determine the sensitivity of a tumor to radiation. This test may help personalize the radiation dose for a person.</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05528133' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/newsroom/press-release-archive/moffitt-researchers-develop-model-to-personalize-radiation-treatment-for-breast-cancer-patients/' target='_blank'>Moffitt Cancer Center: Radiosensitivity Index</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: 6 visits within up to 1 year

PHASE: I

NCT ID: NCT06435351

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> <li class="seamTextUnorderedListItem">Genomic sequencing of tumor sample</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, 3 times within 1.5 months, then up to 2 times within 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called leukapheresis. These cells are processed in a lab so that they will see and go after cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after surgery.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06435351' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/immunotherapy/types/vaccines-to-treat-cancer#:~:text=Dendritic%20cell%20vaccines,system%20to%20attack%20the%20cancer.' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li></ul>

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

VISITS: At least 8 visits

PHASE: II

NCT ID: NCT06245889

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

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

Purpose

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

Who is this for?

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

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">PET scan, 2 times</li> <li class="seamTextUnorderedListItem">ctDNA tests, 4 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), 4 cycles</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), 4 cycles</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), 4 cycles</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if complete response) or additional chemotherapy (if residual disease)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receiving chemotherapy with immunotherapy is called chemo-immunotherapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Complete response to no cancer cells present after chemotherapy.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer to look for signs of disease, including cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06245889' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04523857

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

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

Purpose

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

Who is this for?

People with stage I, stage II, or stage III breast cancer who completed treatment and have one of the following recurrence risk factors: 1) lymph node positive; 2) triple negative (ER-, PR-, HER2-); 3) estrogen receptor positive (ER+), HER2 negative (HER2-), lymph node negative; 4) leftover tumor found in your breast or lymph node (residual disease) after neoadjuvant (before surgery) chemotherapy. You must not have received treatment with a CDK4/6 inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®) is an experimental cancer drug that may help cancer drugs work better.</li> <li class="seamTextUnorderedListItem">The drugs may target bone marrow disseminated tumor cells (DTCs).</li> <li class="seamTextUnorderedListItem">This trial requires bone marrow testing through another research study.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04523857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://i2b.us/repurposing-drugs-as-expanding-cancer-treatment-palette-hydroxychloroquine/' target='_blank'>Institute of Integrative BioOncology: Hydroxychloroquine for Cancer</a> </li></ul>

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

VISITS: 5 visits

PHASE: NA

NCT ID: NCT04959474

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: 10 visits within 5 years

PHASE: II

NCT ID: NCT05949021

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

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

Purpose

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

Who is this for?

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

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

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

VISITS: Coincides with surgery

PHASE: NA

NCT ID: NCT03165487

Breast Tissue Study in Women 40 and Older Having a Lumpectomy

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

Purpose

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

Who is this for?

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

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

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

VISITS: At least 1 visit every 3-6 weeks

PHASE: I-II

NCT ID: NCT06134375

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

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

Purpose

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

Who is this for?

People with stage I, stage II, or stage III triple negative (ER- or ER low, PR- or PR low, HER2-) breast cancer who have received chemotherapy before surgery (neoadjuvant) and surgery within the last 3 months. You must also either have node positive disease after treatment or have a Residual Cancer Burden (RCB) score of 2 or 3. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tetrathiomolybdate, by mouth, daily for 3 years</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 6 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off for 6 months</li> </ul> with or without: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3-6 weeks for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tetrathiomolybdate is a drug that removes copper from the body (copper depletion) and is used to treat other diseases and some advanced cancers.</li> <li class="seamTextUnorderedListItem">Removing copper from the body may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Adding tetrathiomolybdate to standard of care treatment may make the treatment more effective.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Node positive means that cancer has spread to the lymph nodes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06134375' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/copper-depletion-combats-metastatic-recurrence-in-high-risk-tnbc' target='_blank'>OncLive: Tetrathiomolybdate for Triple Negative Breast Cancer</a> </li></ul>

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

VISITS: 1 visit every week for 3 months

PHASE: II

NCT ID: NCT04230109

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

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

Purpose

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

Who is this for?

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

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic (stage IV) triple negative breast cancer. Its use in people with early stage triple negative breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan targets TROP2 proteins and delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04230109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/treatment-of-triple-negative.html' target='_blank'>American Cancer Society: Treatment of Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/diagnosis/trip_neg' target='_blank'>Breastcancer.org: Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/patient/home' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer' target='_blank'>FDA Drug Approvals and Databases: Sacituzumab Govitecan-hziy for Metastatic TNBC</a> </li></ul>

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

VISITS: At least 1 visit every 1-2 weeks

PHASE: I-II

NCT ID: NCT06351332

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

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

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of azenosertib (ZN-C3), an experimental targeted therapy, with carboplatin (Paraplatin®) chemotherapy and pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer who have received 1-3 lines of chemotherapy for advanced disease, including 1 antibody drug conjugate (ADC). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azenosertib (ZN-C3), by mouth, daily, 5 days on, 2 days off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">CT or MRI scans, 4 times in 7 months, then every 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Azenosertib (ZN-C3) is an experimental targeted therapy called a WEE1 inhibitor. Blocking WEE1 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">WEE1 is an important protein in tumor growth.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells. It is currently approved only for PD-L1 positive cancer.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug commonly used to treat breast cancer. it is considered standard of care for breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06351332' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zentalis.com/pipeline/pipeline' target='_blank'>Zentalis Pharmaceuticals: Azenosertib Drug Information Page</a> </li></ul>

No Travel Required

VISITS: No visits required

PHASE: NA

NCT ID: NCT06582615

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

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

Purpose

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

Who is this for?

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

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

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