Clinical Trials

Below is a listing of Clinical Trials supported by the US National Cancer Institute (NCI) for breast cancer that accept men, which I update weekly.

To the right you see a button that allows you to search the trial listings of BreastCancerTrials.org for trials focused on metastatic disease and a link that allows you to do a search on that site for all the trials that accept men.

The list below was compiled by searching the NCI Clinical Trials data base for trials focused on breast cancer as the lead disease, a manually curated piece of information that the team at the NCI provides, and looking for trials that allow men to be enrolled. If you see a trial that is of interest to you, please click through to the NCI’s webpage using the link provided, and find a site offering it near you and then reach out to learn more about whether you are eligible.

This listing contains 6 trials, and was last updated on 2021-05-02

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BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)

A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)

Phase I

This trial includes Her-2 positive tumors, which are very rare among men with breast cancer. Please check your eligibility.

Background: Breast cancer is the second most common cause of U.S. cancer deaths in women. Immunotherapy drugs use a person s immune system to fight cancer. Researchers want to see if a new combination of immunotherapy drugs can help treat breast cancer that has gone to places in the body outside of the breast (metastasized). Objective: To learn if a new combination of immunotherapy drugs can shrink tumors in people with metastatic breast cancer. Eligibility: Adults 18 and older who have been diagnosed with metastatic breast cancer, such as Triple Negative Breast Cancer (TNBC) or ER-/PR-/HER2+ Breast Cancer (HER2+BC) Design: Participants will be screened with: medical history physical exam disease confirmation (or tumor biopsy) tumor scans (computed tomography, magnetic resonance imaging, and/or bone scan) blood and urine tests electrocardiogram (measures the heart s electrical activity) echocardiogram (creates images of the heart). Participants will be assigned to 1 of 3 groups. The drugs they get will be based on the group they are in. Drugs are given in cycles. Each cycle = 3 weeks. Participants will be seen in clinic every 3 weeks, prior to the start of a new cycle. At each visit, participants will have an clinical exam, have blood drawn and will be asked about any side effects. They will repeat the screening tests during the study. New scans, like a CT scan, will be done every 6 weeks to see if the treatment is working. All participants will get BN-Brachyury. It is 2 different vaccines – a prime and a boost. First the priming vaccines, called MVA-BN-Brachyury help to jump start the immune system. Next the boosting vaccines, called FPV-Brachyury help to keep the immune system going. They are injected under the skin during different cycles. All participants will get M7824 (also known as Bintrafusp alfa ), which is an immunotherapy drug. Some participants will get a commonly used drug is HER2+ breast cancer called adotrastuzumab emtansine (also known as T-DM1DM1 or kadcyla). For both, a needle is inserted into a vein to give the drugs slowly. Some participants will take Entinostat weekly by mouth. It is in tablet form. Participants will keep a pill diary. Participants will continue on their assigned treatment until their cancer grows, they develop side effects or want to stop treatment. About 28 days after treatment ends, participants will have a follow-up visit or a telephone call. Then they will be contacted every 3 months for 1 year, then every 6 months for 1 year. They may have more tumor scans or continue treatment.

Start date: 2021-05-04.

This trial is being offered at 1 site(s) including in the following states:

MD | OH

For more information including sites offering the trial visit this NCI page: NCI-2020-01659

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy before Surgery for the Treatment of Patients with Breast Cancer

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

Phase II

This trial includes Her-2 positive tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.

Start date: 2021-05-01.

This trial is being offered at 1 site(s) including in the following states:

WA

For more information including sites offering the trial visit this NCI page: NCI-2020-01662

Pembrolizumab and Tamoxifen with or without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer

Epigenetic Priming for Immune Therapy in ER-Positive Breast Cancer in Biomarker Select Population

Phase II

This phase II trial studies how well pembrolizumab and tamoxifen with or without vorinostat work for the treatment of estrogen receptor positive breast cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen is a type of hormone made by the body that helps develop and maintain female sex characteristics and the growth of long bones. Estrogen may contribute to the growth of breast cancer cells. Tamoxifen blocks the effects of the hormone estrogen in breast tissue, which may help keep breast cancer cells from growing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to find a drug combination to better control estrogen receptor positive breast cancer and reduce the number of pills taken to treat this type of cancer.

Start date: 2021-03-11.

This trial is being offered at 1 site(s) including in the following states:

CA

For more information including sites offering the trial visit this NCI page: NCI-2019-07572

Alpelisib in Combination with Hormone Therapy for the Treatment of Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic or Unresectable Breast Cancer

A Phase II, Single Arm, Non-Randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Phase II

This phase II trial studies the effect of alpelisib given together with hormone therapy in treating patients with hormone receptor positive, HER2 negative, PIK3CA mutant breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy such as anastrozole, letrozole, exemestane, and fulvestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Giving alpelisib together with hormone therapy after progression on hormone therapy may decrease the chance of breast cancer growing or spreading.

Start date: 2021-02-25.

This trial is being offered at 1 site(s) including in the following states:

WI

For more information including sites offering the trial visit this NCI page: NCI-2021-01727

Functional Precision Oncology for HER2 Negative or Non-amplified Metastatic or Recurrent, Unresectable Breast Cancer, FORESEE study

FORESEE: Functional Precision Oncology for Metastatic Breast Cancer: A Feasibility Trial

Phase NA

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This clinical trial investigates if precision oncology may help guide treatment for patients with HER2 negative or non-amplified breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and cannot be removed by surgery (unresectable). Precision oncology uses genetic information from a person’s tumor to help guide the choice of treatment. By looking at the genetic makeup of the cancer, researchers hope to give the right drug to achieve the best response from the treatment (targeted treatment). However, looking at the DNA of the cancer alone does not capture the complex biology of breast cancer and many factors may affect the growth of a cancer. Organoids are generated from a patient’s breast cancer biopsy sample, and are small, live versions of a patient’s cancer. Organoids retain many of the characteristics of the cancer where they came from, including its genetic composition, which makes it easier to evaluate how effective various drugs may be in treating breast cancer. Gathering biopsy samples and exposing them to multiple cancer drugs to see how well they do or do not work may help doctors in choosing a specific treatment plan that is best suited for patients with breast cancer.

Start date: 2021-02-16.

This trial is being offered at 1 site(s) including in the following states:

UT

For more information including sites offering the trial visit this NCI page: NCI-2020-08157

Adjuvant Capecitabine in Treating Patients with Stage I-II Triple-Negative Breast Cancer and Residual Disease

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

Phase II

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase II trial studies the effects of capecitabine in treating patients with stage I-III triple-negative breast cancer. Chemotherapy drugs, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Early stage triple negative breast cancer treated with chemotherapy prior to surgery (neoadjuvant chemotherapy) with residual disease at the time of surgery is associated with a higher risk of cancer coming back (relapse). This study helps researchers identify patients who will or will not experience benefit from capecitabine by monitoring changes in circulating tumor deoxyribonucleic acid (ctDNA) detection in the blood over time while on capecitabine.

Start date: 2021-02-03.

This trial is being offered at 1 site(s) including in the following states:

CA

For more information including sites offering the trial visit this NCI page: NCI-2021-01757


The search strategy used to identify these trials was updated on March 14th, 2021 as described in a recent post.