Study ID: EMERALD
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2-Advanced Breast Cancer (EMERALD)
This randomized phase 3 clinical trial seeks to compare the safety and efficacy of the experimental oral medication elacestrant to the standard of care options of Faslodex® (fulvestrant) or an aromatase inhibitor (AI) in postmenopausal women and in men who have been diagnosed with advanced or metastatic ER+/HER2 negative breast cancer. Eligible patients must have progressed on or within 28 days of completion of prior treatment with CDK4/6 with either fulvestrant or an AI.
Participants are randomized into two study arms:
- Arm 1 receives elacestrant orally once daily
- Arm 2 receives physician’s choice of monotherapy standard of care medications (i.e., fulvestrant, anastrozole, letrozole or exemestane)
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, phase 3 clinical study comparing the efficacy and safety of elacestrant to the standard of care options of fulvestrant or an aromatase inhibitor (AI).
Eligible participants are postmenopausal women and men with advanced or metastatic ER+/HER2 breast cancer either in subjects with tumors that harbor mutations in the ligand binding domain of the estrogen receptor 1 (ESR1) gene or in all subjects regardless of ESR1 status and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression). Prior treatment must have included CDK4/6 inhibitor therapy in combination with fulvestrant or an AI.
- Must have been diagnosed with ER+/HER2-advanced breast cancer
- Must have previously received no more than two endocrine therapies
- Must have had no more than one line of cytotoxic chemotherapy