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New Drug: Elacestrant for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer (EMERALD)

New Drug: Elacestrant for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer (EMERALD)
Study:
  • International, multicenter, randomized, open-label, phase III
  • ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy
  • Elacestrant (n=239) vs. SOC (n=238)
Efficacy:
  • 12 mos PFS in ITT: 22.3 vs. 9.4%, HR: 0.70, p=0.018
  • 12 mos PFS in ESR1 mutant pts: 26.8 vs. 8.2%, HR: 0.55, p=0.0005
  • 12 mos OS in ITT: 79.3 vs. 73.3%, HR: 0.75, p=0.082
  • 12 mos OS in ESR1 mutant pts: 82.6 vs. 73.6%, HR: 0.59, p=0.030
Safety:
  • Grade≥3 AEs: Nausea (2.5% vs.2.9%), back pain )2.5% vs. 0.6%), fatigue (1.5% vs. 0.8%)

J Clin Oncol 2022 40:28, 3246-3256

Bidard F-C et al. ¨Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial ¨

http://doi.org/10.1200/JCO.22.00338

Reviewed by Elvin CHALABİYEV, MD on FEB 24, 2023

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