Sponsor: Stemline Therapeutics, Inc
Sponsor Study ID: STML-ELA-0422
Study Title: Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
CTO #: 104093
NCT Number: NCT06492616
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Breast
Study Objectives: Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of IBCFS in participants with node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high risk of recurrence. Evaluate the efficacy of elacestrant relative to standard of care (SoC) in terms of distant relapse-free survival (DRFS). Evaluate the efficacy of elacestrant relative to SoC in terms of overall survival (OS).