Opinion|Videos|October 23, 2025

EMERALD Trial Design and Baseline Characteristics

The phase 3 randomized trial enrolled 694 patients with ER+/HER2– disease, stratified by ESR1 mutation status and prior therapies, to compare elacestrant versus standard-of-care endocrine treatments.

The study enrolled 694 patients randomly assigned 1:1 to receive elacestrant or physician’s choice of standard therapy. Stratification factors included ESR1 mutational status, visceral metastases, and prior fulvestrant use. The primary end point was progression-free survival, with overall survival as a secondary end point. The patient population primarily consisted of those previously treated with CDK4/6 inhibitors and up to one prior chemotherapy line.

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