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 3 trials, and was last updated on 2023-01-16

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A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer

Phase II

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

The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.

Start date: 2022-11-17.

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

CO | NM

For more information including sites offering the trial visit this NCI page: NCI-2022-10204

Study of TTI-101 in Combination for Participants With Metastatic Hormone Receptor-Positive and Human Epithelial Receptor 2 (HER2)-Negative Breast Cancer

Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance on First- Line Palbociclib Plus Aromatase Inhibitor Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Phase I_II

The primary objectives of the Phase 1b part of this study are to evaluate the safety and tolerability of TTI-101 when added to palbociclib and aromatase inhibitor (AI) administered orally to participants with estrogen receptor-positive (ER+) human epithelial receptor 2-negative (HER2-) palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI. The primary objective of the Phase 2 part of this study is to evaluate tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria in participants who receive TTI-101 added to palbociclib and AI.

Start date: 2022-11-01.

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

MO | TX

For more information including sites offering the trial visit this NCI page: NCI-2022-08022

Genetically-Guided Radiotherapy for the Treatment of Triple Negative Breast Cancer in Patients Undergoing Breast Conservation Surgery

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

Phase II

This phase II trial tests the effect of genetically-guided radiotherapy in treating triple negative breast cancer in patients undergoing an operation to remove the breast cancer but not the breast itself (breast conservation surgery). In this study, patient tumor tissue is collected and tested for certain genes to calculate the risk of cancer recurrence (“high risk” or “low risk”) and determine the amount of radiotherapy patients should receive. This test is called radiosensitivity index (RSI). Radiotherapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving genetically-guided radiotherapy may be feasible and effective in controlling triple-negative breast cancer following breast conservation surgery.

Start date: 2022-11-01.

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-2022-09416


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