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 5 trials, and was last updated on 2021-10-18

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A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician’s Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

Phase III

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Start date: 2021-08-27.

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

CA | IA

For more information including sites offering the trial visit this NCI page: NCI-2021-09253

Genomically Directed Therapy with Capecitabine after Surgery for the Treatment of Residual Stage I-III Invasive Triple Negative Breast Cancer, PERSEVERE study

A Phase II Circulating Tumor DNA Enriched, Genomically Directed Post-Neoadjuvant Trial for Patients with Residual Triple Negative Breast Cancer (PERSEVERE)

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 using certain medication combinations or a standard treatment approach based on presence of circulating tumor in the blood (liquid biopsy) and identification of genetic differences in the tumor in treating patients with stage I-III invasive triple negative breast cancer. DNA is a record of instructions telling the cells what their job will be such as determining eye color or hair color. This study includes extracting blood and tumor DNA and then performing “next generation sequencing” testing. Next generation sequencing is a new way to look at abnormalities and differences in the DNA obtained from the tumor. This study will use two tests to determine study treatment assignment. The first test is looking at whether patients have circulating tumor DNA (ctDNA) in their blood. When chemotherapy kills the tumor, it releases cells into the blood stream or ctDNA. Studies show that patients with positive ctDNA may be at greater risk to relapse after surgery. The second test will look at the tumor’s DNA abnormalities (genomic target). If patients are positive for ctDNA in their blood and they have a genomic target in their tumor tissue, then they will be assigned to receive one of four “directed” therapy combinations. 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. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Inavolisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving genomically directed therapy may work better than standard treatment in treating patients with residual stage I-III invasive triple negative breast cancer.

Start date: 2021-08-25.

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

IN

For more information including sites offering the trial visit this NCI page: NCI-2021-07692

Single Fraction Accelerated Partial Breast Irradiation or Five Fraction Accelerated Partial Breast Irradiation for the Treatment of Low-risk Stage 0 and I Breast Cancer

Evaluation of Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma

Phase NA

This clinical trial compares the use of single fraction accelerated partial breast irradiation with five fraction accelerated partial breast irradiation in treating patients with low-risk stage 0 and I breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Single fraction accelerated partial breast irradiation is radiation therapy given in a single day. Five fraction accelerated partial breast irradiation is radiation therapy given over the course of five days. Giving single fraction accelerated partial breast irradiation after surgery may work better in reducing the risk of breast cancer coming back compared to five fraction accelerated partial breast irradiation.

Start date: 2021-08-12.

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

MO

For more information including sites offering the trial visit this NCI page: NCI-2021-05051

Stereotactic Radiosurgery, Abemaciclib, and Endocrine Therapy for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases

Phase I_II

This phase I/II trial studies the effect of stereotactic radiosurgery, abemaciclib, and endocrine (hormone) therapy in treating patients with hormone receptor positive HER2 negative breast cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely deliver radiation to a tumor. The total dose of radiation is sometimes divided into several smaller doses given over several days. It is also called stereotactic external-beam radiation therapy. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Aromatase inhibitor is an endocrine therapy that lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Fulvestrant is an endocrine therapy that blocks the use of estrogen by the tumor cells. Giving stereotactic radiosurgery together with abemaciclib and endocrine therapy may work better in treating patients with breast cancer brain metastases compared to stereotactic radiosurgery alone.

Start date: 2021-07-28.

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

FL

For more information including sites offering the trial visit this NCI page: NCI-2021-08582

Niraparib, Dostarlimab, and Radiation Therapy for the Treatment Metastatic PD-L1 Negative or Immunotherapy-Refractory Triple Negative Breast Cancer, the NADiR Study

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

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 of the effect of niraparib, dostarlimab, and radiation therapy in treating patients with PD-L1 negative triple negative breast cancer that has spread to other places in the body (metastatic) or did not respond to previous immunotherapy (immunotherapy-refractory). Niraparib is a type of drug called a “PARP inhibitor”, which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage associated with cancer from occurring. Dostarlimab is a type of inhibitor that is believed to work by inhibiting (stopping) a protein called PD-1 from working. The PD-1 protein controls parts of the immune system (the system in the body that fights against diseases) by shutting down certain immune responses that are responsible for recognizing and destroying cancer cells. Dostarlimab may inhibit the PD-1 protein on cancer cells, thus allowing immune cells to recognize and destroy cancer cells. Radiation therapy is a standard-of-care treatment that is given to stop the growth of tumors. Radiation therapy can also stimulate the immune system, which leads to the destruction of tumor cells in the treated areas. Combining radiation therapy with anti-cancer drugs like dostarlimab and niraparib may increase the ability of the immune system to control or destroy cancer cells throughout the body.

Start date: 2021-07-21.

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-2021-08759


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