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 2022-05-23

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Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

Phase I_II

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting.

Start date: 2022-04-21.

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

CO | NC

For more information including sites offering the trial visit this NCI page: NCI-2021-10133

Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients with Triple-Negative Inflammatory Breast Cancer that has Spread to Other Parts of the Body

Phase Ib/II Study of EPA-Based EphA2 Targeted Therapy for Patients with Metastatic Triple-Negative Inflammatory Breast Cancer

Phase I_II

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

This phase Ib/II tests the safety, side effects, and best dose of icosapent ethyl in combination with dasatinib and whether they work to shrink tumors in patients with triple-negative inflammatory breast cancer that has spread to other places in the body (metastatic). Triple-negative inflammatory breast cancer is a type of inflammatory breast cancer in which the tumor cells do not have estrogen receptors, progesterone receptors, or large amounts of HER2/neu protein on their surface. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Icosapent ethyl is an omega-3 fatty acid and in a class of medications called antilipemic or lipid-regulating agents. It may decrease the amount of triglycerides and other fats made in the liver. Preclinical studies have suggested that it may reduce the growth of triple negative inflammatory breast cancer cells. Combination therapy with dasatinib and icosapent ethyl may help shrink tumors in patients with triple-negative inflammatory breast cancer.

Start date: 2022-03-25.

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

For more information including sites offering the trial visit this NCI page: NCI-2022-00004

Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients with Advanced/Metastatic or Unresectable Solid Tumors with RAS Alterations and Triple Negative Breast Cancer

A Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast Cancer

Phase I

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

This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with Binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination.

Start date: 2022-03-15.

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

For more information including sites offering the trial visit this NCI page: NCI-2021-11793

Panitumumab and Pembrolizumab in Combination with Neoadjuvant Chemotherapy for the Treatment of Stage III-IV Triple Negative Breast Cancer

Enhancing Immunotherapy by Targeting the EGFR Pathway in Inflammatory Breast Cancer: A Phase II Study of Panitumumab (PmAb) and Pembrolizumab (Pembro) in Combination with Neoadjuvant Chemotherapy (NAC) in Patients with Newly Diagnosed Triple Negative Inflammatory Breast Cancer (TN-IBC)

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 tests whether panitumumab and pembrolizumab in combination with standard of care chemotherapy before surgery (neoadjuvant) works to shrink tumors in patients with stage III-IV triple negative breast cancer. Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. 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. Chemotherapy drugs, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide 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. Giving panitumumab and pembrolizumab in combination with neoadjuvant chemotherapy may kill more tumor cells in patients with triple negative breast cancer.

Start date: 2022-03-11.

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

TX

For more information including sites offering the trial visit this NCI page: NCI-2021-13704

Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician’s Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician’s Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

Phase I_II

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

This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section). Once the subject has recovered from SRS, Cycle 2 will be initiated with physician’s choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician’s choice systemic monotherapy will be given along with durvalumab per section 5.3. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death.

Start date: 2022-03-09.

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-2021-05777

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05)

Phase III

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

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

Start date: 2022-03-07.

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

CA | GA | NJ | OH | WA

For more information including sites offering the trial visit this NCI page: NCI-2022-00541


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