Clinical Trial

Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

Study acronym: ELECTRA
Recruiting Phase 1/2
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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.
Protocol Amendment History 30 amendments
This ClinicalTrials.gov record has been amended 30 times since 2022-05-18; most recent amendment 2026-06-03.
Status change: Not Yet Recruiting → Recruiting 2022-09-07
Trial Details
NCT Number NCT05386108
Lead Sponsor Stemline Therapeutics, Inc.
Conditions Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Central Nervous System Neoplasms, Brain Diseases, Central Nervous System Diseases
Enrollment 73 participants
Start Date 2022-08-31
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-06