EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer

Aditya Bardia, Philippe Aftimos, Teeru Bihani, Alfred T. Anderson-Villaluz, Jungah Jung, Maureen G. Conlan, Virginia G. Kaklamani

Research output: Contribution to journalReview article

8 Scopus citations

Abstract

Elacestrant is a novel, nonsteroidal, orally bioavailable selective estrogen receptor degrader (SERD) that has demonstrated activity in patients with estrogen receptor (ER)-positive/HER2-negative breast cancer previously treated with endocrine therapies including fulvestrant and/or CDK 4/6 inhibitor therapy, and in those with ESR1 mutations (ESR1-mut) known to confer endocrine resistance. Herein, we describe the design and methodology of EMERALD, an international, multicenter, randomized, open-label, active-controlled, Phase III clinical study comparing the efficacy and safety of elacestrant to standard-of-care endocrine monotherapy treatment (fulvestrant or an aromatase inhibitor, per investigator's choice) in patients with ER-positive/HER2-negative advanced breast cancer. Primary end points are progression-free survival in ESR1-mut patients and in all patients (NCT03778931; EudraCT 2018-002990-24).

Original languageEnglish (US)
Pages (from-to)3209-3218
Number of pages10
JournalFuture Oncology
Volume15
Issue number28
DOIs
StatePublished - Jan 1 2019
Externally publishedYes

Keywords

  • ESR1 mutation
  • RAD1901
  • aromatase inhibitor
  • breast cancer
  • elacestrant
  • endocrine therapy
  • estrogen receptor (ER)-positive
  • fulvestrant
  • selective estrogen receptor degrader (SERD)

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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