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 12 trials, and was last updated on 2021-07-11

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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: 2021-07-01.

This trial is being offered at including in the following states:

WA

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

Trastuzumab Emtansine Followed by Trastuzumab versus Paclitaxel in Combination with Trastuzumab for the Treatment of HER2-Positive Stage I Breast Cancer, ATEMPT 2.0 Trial

A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab versus Paclitaxel in Combination with Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)

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 effects of trastuzumab emtansine followed by trastuzumab versus paclitaxel with trastuzumab in treating patients with HER2-positive stage I breast cancer. Trastuzumab emtansine is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. 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 is a monoclonal antibody, which are disease-fighting proteins made by cloned immune cells. Giving trastuzumab emtansine followed by trastuzumab may have less side-effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel.

Start date: 2021-06-16.

This trial is being offered at including in the following states:

MA

For more information including sites offering the trial visit this NCI page: NCI-2021-06637

Vitamin D Supplementation for the Improvement of Pathologic Complete Response in Vitamin D Deficient Patients Receiving Neoadjuvant Chemotherapy for Operable 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

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 effect of vitamin D supplementation in improving pathologic complete response in vitamin D deficient patients who are receiving neoadjuvant chemotherapy for triple negative breast cancer that can be removed by surgery (operable). There is evidence that vitamin D may have anti-cancer properties. This trial aims to see whether adding weekly vitamin D supplementation to standard of care chemotherapy may help to improve treatment response in vitamin D deficient patients.

Start date: 2021-06-14.

This trial is being offered at including in the following states:

NC

For more information including sites offering the trial visit this NCI page: NCI-2021-06483

Testing the Usual Treatment of Radiation Therapy and Hormonal Therapy to Hormonal Therapy alone for Low-Risk, Early Stage Breast Cancer, the DEBRA Trial

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer (DEBRA)

Phase III

This phase III trial compares the effect of radiation therapy combined with hormonal therapy versus hormonal therapy alone in treating patients with low risk, early stage breast cancer with Oncotype Dx Recurrence =< 18. Oncotype DX is a laboratory test which results in a score that is used to help predict whether breast cancer will spread to other parts of the body or come back. Radiation therapy uses high doses of radiation to kill cancer cells and shrink tumors but may result in some side effects. Hormones called estrogen and progesterone may contribute to the growth of breast tumor cells. Hormone therapy, also called endocrine therapy, may stop the growth of tumor cells by blocking or removing these hormones. This clinical trial may help researchers understand if patients with low-risk, early stage breast cancer who have Oncotype recurrence score of =< 18 can safely omit radiation therapy and only be treated with hormonal therapy without losing any radiation treatment benefit.

Start date: 2021-06-07.

This trial is being offered at including in the following states:

IL | MI | MO | NY

For more information including sites offering the trial visit this NCI page: NCI-2021-00222

Abemaciclib and Niraparib before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

A Phase 1 Study of Abemaciclib and Niraparib as Neoadjuvant Therapy in Hormone Receptor Positive (HR+) HER2 Negative (HER2-) Breast Cancer

Phase I

This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2 negative. Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working so tumor cells can’t repair themselves and grow. Giving abemaciclib and niraparib together before surgery may make the tumor smaller.

Start date: 2021-06-07.

This trial is being offered at including in the following states:

OR

For more information including sites offering the trial visit this NCI page: NCI-2020-03813

Avelumab or Hydroxychloroquine with or without Palbociclib for the Treatment of Stage II-III Breast Cancer, PALAVY Study

A Phase II Trial of Avelumab or Hydroxychloroquine with or without Palbociclib to Eliminate Dormant Breast Cancer (“PALAVY”)

Phase II

This phase II trial investigates the effect of avelumab or hydroxychloroquine sulfate with or without palbociclib in treating patients with stage II-III breast cancer that is positive for disseminated tumor cells (DTCs) after curative therapy. DTCs are breast cancer cells that are asleep (dormant) in the bone marrow. There are multiple ways in which these cells stay alive, and three of these mechanisms are inhibited by the drugs in this trial. First, dormant cancer cells need a protein signal pathway involving CDK 4/6 to start dividing once they wake up in order to survive as an active cancer cell. Palbociclib works by blocking the CDK 4/6 protein and by doing so may limit the dormant cancer cell from being able to survive. In addition, palbociclib may also help both of the other drugs in the trial to work better. Second, dormant cancer cells also use a process called “autophagy” to generate their own nutrition, which can allow them to stay asleep. Hydroxychloroquine has been shown to block autophagy, which leads to starvation of the cells. Third, dormant cancer cells are able to hide from the body’s immune system. The immune system sends a type of cell called T cells throughout the body to detect and fight infections and diseases—including cancers. One way the immune system controls the activity of T cells is through the PD-1/PD-L1 (programmed cell death protein-1) pathway. However, some cancer cells hide from T-cell attack by taking control of the PD-1/PD-L1 interaction and this stops T cells from attacking cancer cells. Avelumab is an antibody designed to block the PD-1/PD-L1 pathway and helps the immune system in detecting and fighting dormant cancer cells. Because palbociclib, hydroxychloroquine, and avelumab work on the mechanisms that keep the dormant cells alive, taking one or a combination of these drugs may be able to eliminate DTCs.

Start date: 2021-06-01.

This trial is being offered at including in the following states:

PA

For more information including sites offering the trial visit this NCI page: NCI-2021-06208

Onapristone and Fulvestrant for Patients with ER-Positive, HER2 Negative Metastatic Breast Cancer

A Phase II Trial of OnapriStone in CoMbInation with FuLvestrant for Patients with ER-Positive, and HER2-Negative Metastatic Breast Cancer after Progression on Endocrine Therapy and CDK 4/6 Inhibitors (The SMILE Study)

Phase II

This phase II trial studies the effect of onapristone and fulvestrant in treating patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has spread to other places in the body (metastatic). Progesterone is a hormone that is responsible for regulating the menstrual cycle. In patients with progesterone receptor positive tumors, the tumor cells take control of the progesterone and use it to help grow and spread. Onapristone stops progesterone from attaching to tumor cells so the cells can’t use it to grow anymore. Because onapristone works by adjusting hormones, it’s considered a hormone therapy. Estrogen can cause the growth of breast cancer cells. Fulvestrant blocks the use of estrogen by the tumor cells. Giving onapristone in combination with fulvestrant may work to stop or slow the growth of ER positive HER2 negative metastatic breast cancer.

Start date: 2021-05-24.

This trial is being offered at including in the following states:

WI

For more information including sites offering the trial visit this NCI page: NCI-2021-00371

A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

Phase III

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

The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.

Start date: 2021-05-10.

This trial is being offered at including in the following states:

CA | CO | TX

For more information including sites offering the trial visit this NCI page: NCI-2021-03320

Capivasertib + Palbociclib + Fulvestrant for HR+/HER2- Advanced Breast Cancer (CAPItello-292).

A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer

Phase III

A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292).

Start date: 2021-05-10.

This trial is being offered at including in the following states:

CO

For more information including sites offering the trial visit this NCI page: NCI-2021-06969

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 including in the following states:

MD | OH

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

A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Phase III

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

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

Start date: 2021-05-04.

This trial is being offered at including in the following states:

CA | TX

For more information including sites offering the trial visit this NCI page: NCI-2021-04294

A Study of U3-1402 in Subjects With Metastatic Breast Cancer

A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer

Phase II

This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 in patients with metastatic breast cancer (MBC) who have received no prior anti-HER2 therapy.

Start date: 2021-05-03.

This trial is being offered at including in the following states:

CA | NJ | WA

For more information including sites offering the trial visit this NCI page: NCI-2021-03405


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