OncoMatch/Clinical Trials/NCT05501704
ETHAN - ET for Male BC
Is NCT05501704 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tamoxifen and Anastrozole for male breast cancer.
Treatment: Tamoxifen · Anastrozole · Degarelix · Abemaciclib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>1% positive tumor nuclei by IHC)
positivity for at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR]) by IHC. ER and PR assays are considered positive if there are > 1% positive tumor nuclei in the samples.
Required: PR (PGR) overexpression (>1% positive tumor nuclei by IHC)
positivity for at least one of the hormone receptors (estrogen receptor [ER] or progesterone receptor [PR]) by IHC. ER and PR assays are considered positive if there are > 1% positive tumor nuclei in the samples.
Required: HER2 (ERBB2) negative (HER2-negative per ASCO/CAP guideline)
HER2-negative is defined per the current American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline (113).
Disease stage
Required: Stage I, II, III (AJCC 8th edition)
Excluded: Stage T4D
Stage I, II, or III per American Joint Committee on Cancer (AJCC) staging 8th edition (112)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: endocrine therapy
Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.
Cannot have received: chemotherapy
Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.
Cannot have received: radiation therapy
Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.
Cannot have received: investigational therapy
Prior endocrine therapy, chemotherapy, radiation therapy, or investigational therapy for the current breast cancer diagnosis.
Cannot have received: endocrine therapy
Exception: allowed if >12 months prior
Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.
Cannot have received: systemic therapy
Exception: allowed if >12 months prior
Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.
Cannot have received: radiation therapy
Exception: allowed if >12 months prior
Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.
Cannot have received: investigational therapy
Exception: allowed if >12 months prior
Prior endocrine therapy, systemic therapy, radiation therapy, or investigational therapy for any other malignancy within the past 12 months.
Lab requirements
Blood counts
ANC ≥ 1000/mm3; Hemoglobin ≥ 8 g/dl; Platelets ≥ 50,000/mm3
Kidney function
Serum creatinine ≤ 3.0 x ULN (institutional)
Liver function
Total bilirubin ≤ 2.0 x ULN (institutional); AST and ALT ≤ 5.0 x ULN (institutional)
Required laboratory values demonstrating adequate organ function: ANC ≥ 1000/mm3; Hemoglobin ≥ 8 g/dl; Platelets ≥ 50,000/mm3; Serum creatinine ≤ 3.0 x ULN (institutional); Total bilirubin ≤ 2.0 x ULN (institutional). AST and ALT ≤ 5.0 x ULN (institutional)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Georgetown University Medical Center · Washington D.C., District of Columbia
- Dana Farber Cancer Institute · Boston, Massachusetts
- Mayo Clinic · Rochester, Minnesota
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
- University of Pennsylvania, Abramson Cancer Center · Philadelphia, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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