Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 26, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT02311933). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 81 participants (ACTUAL). Conditions: Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7. Interventions: DRUG: Endoxifen Hydrochloride; OTHER: Laboratory Biomarker Analysis; OTHER: Pharmacological Study; DRUG: Tamoxifen Citrate. Primary outcome measures: Progression Free Survival (PFS) , Assessed up to 5 years. Brief summary: This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.