Clinical Trial

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Study acronym: ELEVATE
Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This is a multicenter, Phase 1b/2 trial in participants with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced/metastatic breast cancer. The phase 1b part of the trial will determine the recommended Phase 2 dose (RP2D) of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, capivasertib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-13
notable Trial sites reduced: 118 -> 83 locations 2026-06-13
Trial Details
NCT Number NCT05563220
Lead Sponsor Stemline Therapeutics, Inc.
Conditions Breast Cancer, Metastatic Breast Cancer
Enrollment 435 participants
Start Date 2023-01-24
Primary Completion 2026-12-27 (estimated)
Study Completion 2028-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-12