Sarah Sammons, MD, discusses findings from the phase 3 EMERALD trial in estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.
Sarah Sammons, MD, assistant professor of medicine, Department of Medicine, Duke University School of Medicine, member, Duke Cancer Institute, Duke Health, discusses findings from the phase 3 EMERALD trial (NCT03778931) in estrogen receptor (ER)–positive, HER2-negative advanced or metastatic breast cancer.
EMERALD is the first randomized phase 3 trial evaluating an oral selective ER degrader to read out, Sammons says. The study enrolled 477 men and postmenopausal women with advanced or metastatic ER-positive, HER2-negative breast cancer who had progressed or relapsed on 1 or 2 lines of endocrine therapy, 1 of which was given with a CDK4/6 inhibitor in the metastatic setting. Patients were randomized 1:1 to 400 mg of elacestrant daily or investigator’s choice of standard-of-care endocrine therapy with fulvestrant (Faslodex), anastrozole, letrozole, or exemestane. The co-primary end points were progression-free survival (PFS) in the intention-to-treat (ITT) population and PFS in the ESR1-mutant subgroup.
The findings showed a statistically significant improvement in PFS in the ITT population; the median PFS was 2.79 months with elacestrant vs 1.91 months with standard endocrine therapy, resulting in a hazard ratio of 0.697. In the ESR1-mutant subgroup, the median PFS was 3.78 months with elacestrant vs 1.87 months with standard endocrine therapy, resulting in a hazard ratio of 0.546 and greater magnitude of benefit, Sammons concludes.