EMERALD trial - elacestrant in hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer

Last edited 05/2023 and last reviewed 07/2023

Endocrine therapy represents the cornerstone of treatment in hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (mBC)

  • the natural course of this disease is marked by endocrine resistance, mainly due to Estrogen Receptor 1 (ESR1) acquired mutation (1)

The EMERALD trial, was an international, open-label, randomized phase III trial that evaluated the efficacy and safety of the oral selective estrogen receptor degrader, elacestrant, versus endocrine monotherapy (standard-of-care [SOC]) in patients with previously treated estrogen receptor (ER)-positive, HER2-negative advanced breast cancer, including patients with ESR1-mutated tumors

  • elacestrant is a novel, oral selective ER degrader
  • demonstrated a significant progression-free survival (PFS) improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer
  • is suggested that this evidence provides a strong signal for role of testing in activating gain-of-function mutations in the estrogen receptor gene ligand-binding domain (ESR1 mutation) to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC)

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