Which hormone treatments work best for men's breast cancer

Predicting Endocrine Therapy Response In Male Breast Tumors

NIH-funded research Univ of North Carolina Chapel Hill · NIH-11122328

This project compares three hormone therapy regimens for men with ER-positive, HER2-negative breast cancer to find which reduces tumor activity and cancer burden the most.

Quick facts

Grant typeR37 grant
Study typeNIH-funded research
Funding institutionUniv of North Carolina Chapel Hill NIH-funded
Lab location1 site (Chapel Hill, United States)
Project IDNIH-11122328 on NIH RePORTER

What this research studies

If you join, you will be randomly assigned to one of three endocrine (hormone) treatments and have a short 3-week 'window' period followed by a tumor biopsy. After that you'll enter a four-month pre-surgery phase where some patients will also receive the CDK4/6 drug abemaciclib, then have surgery to remove the tumor. Researchers will compare changes in tumor growth markers (like Ki-67) and residual cancer after treatment and will sequence tumor samples before and after treatment to look for gene-expression patterns linked to response. The goal is to build a multigene signature that could help predict which men will respond best to each hormone therapy.

Who could benefit from this research

Good fit: Men diagnosed with ER-positive, HER2-negative breast cancer who are candidates for neoadjuvant endocrine therapy and willing to undergo tumor biopsies and surgery.

Not a fit: People with ER-negative or HER2-positive tumors, women, or anyone unwilling or unable to have biopsies, four months of pre-surgery therapy, or surgery are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, this could help doctors choose the most effective hormone treatment for individual men with ER+/HER2- breast cancer.

How similar studies have performed: Similar short 'window' Ki-67 studies and neoadjuvant endocrine plus CDK4/6 approaches have shown predictive signals in women, but applying these methods specifically to men is novel.

Where this research is happening

Chapel Hill, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Breast CancerBreast Cancer Patient
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.