Protocol Title: A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)

Sponsor: Stemline

Protocol Number: STML-ELA-0222 “ELEVATE”

Key Criteria

·         Histopathologically or cytologically confirmed ER+, HER2 negative
·         1 measurable lesion per RECIST 1.1
·         Men or women eligible
Prior chemotherapy or elacestrant in the advanced/metastatic setting.

Talking Points

·         Dealer’s choice on which drug to combine with Elacestrant
·         All subjects receive elacestrant
·         Other medications for the combination cohorts: alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib
·         All medications are provided by study
·         Travel to site is covered by study budget
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