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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 9, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT05386108). This is a study registration, not published results. Lead sponsor: Stemline Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 73 participants (ESTIMATED). Conditions: Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases. Interventions: DRUG: Elacestrant; DRUG: Abemaciclib. Primary outcome measures: Phase 1b: RP2D , Cycle 1 (28 days); Phase 2: Objective Response Rate (ORR) Per Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) , 3 years. Brief summary: This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.