ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer
Jose Pablo Leone
Summary
This research study is looking to see how well male breast cancer responds to preoperative treatment with endocrine therapy and which endocrine therapy regimen is the most effective treatment for male breast cancer. The drugs used in this study are: * Tamoxifen * Anastrozole * Degarelix * Abemaciclib
Description
This is an open-label, multicenter, randomized trial for men with stage I-III hormone receptor-positive (HR+)/HER2-negative breast cancer. The trial will have two phases: A 3-week window phase containing endocrine therapy followed by a 4-month treatment phase where participants are treated with one of four endocrine therapy treatment combinations. Tamoxifen is the standard of care for the treatment of breast cancer in men. Anastrozole is a standard treatment in women with breast cancer and works more effectively than tamoxifen. This study hopes to learn if anastrozole may also be effective in…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men aged 18 years or older, with diagnosis of invasive breast cancer who have not undergone surgical resection of the primary tumor and axillary nodes. * Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112). * Breast cancer must be hormone receptor-positive and HER2-negative according to definition below assessed by local pathology. * Hormone receptor-positive is defined as: positivity for at least one of the hormone receptors (estrogen receptor \[ER\] or progesterone receptor \[PR\]) by IHC. ER and PR assays are considered posit…
Interventions
- DrugTamoxifen
Taken orally
- DrugAnastrozole
Taken orally
- DrugDegarelix
Subcutaneous (under the skin) injection
- DrugAbemaciclib
Taken orally
Locations (8)
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Dana Farber Cancer InstituteBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
- University of Pennsylvania, Abramson Cancer CenterPhiladelphia, Pennsylvania
- University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania