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)
Objective
Primary Objective: 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.
Key Secondary Objectives: 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).
Secondary Objectives: Evaluate the efficacy of elacestrant relative to SoC in terms of invasive disease-free survival (IDFS). Characterize the safety of elacestrant in the trial patient population. Evaluate the effect of elacestrant relative to SoC on patient-reported outcomes (PROs). Characterize elacestrant steady-state pharmacokinetics (PK) and exposure-response relationships (efficacy and safety) in a subset of participants enrolled in the elacestrant arm at United States (US) clinical sites.
