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 III Study
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Asif, Samia
Contact Information:
Brandy Bach
brbach@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06492616?term=NCT06492616&rank=1#participation-criteria
Summary
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.
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). -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.