EMERALD

NCT03778931 📎

Regimen

Experimental
Elacestrant 400 mg daily (oral SERD).
Control
Investigator's choice of endocrine monotherapy (fulvestrant or aromatase inhibitor).

Population

Men and postmenopausal women with HR+/HER2- advanced breast cancer who had received 1-2 prior lines including a CDK4/6 inhibitor; included and ESR1-mutant biomarker cohort.

Key finding

EMERALD established elacestrant as the first oral SERD approved in the post-CDK4/6 setting, specifically for ESR1-mutant HR+/HER2- metastatic disease. FDA approved January 2023; NCCN BINV-P lists elacestrant for ESR1-mutant tumors after progression on prior endocrine plus CDK4/6.

Source: PMID 35584336

Timeline

  • Publication: 2022 Oct 1

Guideline citations

  • NCCN BREAST