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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT02860000). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 96 participants (ACTUAL). Conditions: Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer. Interventions: DRUG: Alisertib; DRUG: Fulvestrant; OTHER: Laboratory Biomarker Analysis. Primary outcome measures: Tumor Response Rate Defined as 100% Times the Number of Patients Who Meet the Criteria for Complete Response (CR) or Partial Response (PR) Using RECIST Criteria Version 1.1 , Up to 4.5 years. Brief summary: This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer.