ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer
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
Detailed 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 men. Given that gonadal suppression and CDK 4/6 inhibitors have both improved treatment in women with breast cancer, the study hopes to learn how the addition of Degarelix (gonadal suppression) and Abemaciclib (CDK 4/6 inhibitors) work in comparison to standard of care tamoxifen. The research study procedures include screening for eligibility and study treatment including laboratory evaluations and quality of life questionnaires. After completion of treatment, participants will be followed for up to 10 years It is expected that about 60 men will take part in this research study. Eli Lilly, a pharmaceutical company, is supporting this research study by providing one of the study drugs. This study is also being supported by Johns Hopkins University on behalf of the Translational Breast Cancer Research Consortium (TBCRC).
Arms & interventions
- DrugTamoxifen
Taken orally
- DrugAnastrozole
Taken orally
- DrugDegarelix
Subcutaneous (under the skin) injection
- DrugAbemaciclib
Taken orally
Outcome measures
Primary
Change in Ki-67
Ki-67 will be evaluated by ImmunoHistoChemistry (IHC) following consensus recommendations using imaging analysis methods.
Time frame: At the end of the 3-week window period.
RCB index
RCB will be determined using data from each participating institution pathology department, and will be reviewed by the study team pathologist.
Time frame: At time of surgery.
Secondary
Changes in estradiol levels
Time frame: Baseline and at the end of the three-week window period
Changes in testosterone levels
Time frame: Baseline and at the end of the three-week window period
Preoperative Endocrine Prognostic Index (PEPI) score
Time frame: At time of surgery
Eligibility criteria
Study locations (8)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Mayo Clinic
Rochester, Minnesota, 55905
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Vanderbilt Cancer Center
Nashville, Tennessee, 37232
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009