Actively Recruiting
ETHAN - ET for Male BC
Led by Jose Pablo Leone · Updated on 2026-04-30
60
Participants Needed
8
Research Sites
650 weeks
Total Duration
On this page
Sponsors
J
Jose Pablo Leone
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ETHAN - ET for Male BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older with invasive breast cancer not yet surgically removed
- Stage I, II, or III breast cancer according to AJCC 8th edition
- Breast cancer must be hormone receptor-positive (ER or PR positive >1%) and HER2-negative
- Multifocal, multicentric, or bilateral breast cancers eligible if treated as ER-positive and HER2-negative
- History of DCIS or LCIS allowed
- ECOG performance status of 2 or less
- Adequate organ function as shown by specific laboratory values (ANC, hemoglobin, platelets, creatinine, bilirubin, AST, ALT)
- Men with partners of childbearing potential must use effective non-hormonal contraception during treatment and 6 months after
- Non-English speakers eligible but exempt from patient questionnaires
- Willing and able to sign informed consent
- Willing to undergo breast biopsy after the initial window phase
- Able to swallow oral medications
You will not qualify if you...
- Prior endocrine therapy, chemotherapy, radiation, or investigational treatment for current breast cancer
- Prior systemic or investigational therapy for any other cancer within past 12 months
- Diagnosis of inflammatory breast cancer (T4d)
- Serious concurrent diseases interfering with treatment such as severe cardiac disease, CHF NYHA Class III or higher, severe lung disease, uncontrolled infections
- Serious uncontrolled medical conditions judged by investigator, including interstitial lung disease, severe dyspnea requiring oxygen, severe renal impairment, major prior gastrointestinal surgery, Crohn's disease, ulcerative colitis, or chronic diarrhea Grade 2 or higher
- Active systemic bacterial, fungal, or viral infections, including HIV or active hepatitis B or C
- Personal history of syncope from heart causes, pathological ventricular arrhythmias, or sudden cardiac arrest
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Actively Recruiting
Research Team
J
Jose Pablo Leone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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