Elacestrant Shows Promise in Treating Estrogen-Receptor Positive Metastatic Breast Cancer

In a promising development for patients with estrogen receptor-positive (ER+)/HER2-negative (HER2-) metastatic breast cancer, elacestrant has been shown to significantly prolong progression-free survival (PFS) and improve clinical outcomes in patients who have not been treated with CDK4/6 inhibitors (CDK4/6i). The phase 3 EMERALD trial found that elacestrant reduced the risk of progression or death by 30% in the overall population and by 45% in patients with ESR1 mutated tumors. Elacestrant has been approved as the first clinically available oral selective estrogen receptor degrader (SERD) and is now being evaluated in a phase 2 trial, ELCIN, which will assess its efficacy and safety in patients with ER+/HER2- metastatic breast cancer who received prior ET and no prior CDK4/6i in the metastatic setting.

Key Takeaways:

  • Elacestrant significantly prolonged progression-free survival (PFS) compared to standard-of-care (SOC) ET, with a 30% reduced risk of progression or death in the overall population (HR, 0.70; 95% CI, 0.55-0.88; P = .002).
  • Elacestrant reduced the risk of progression or death by 45% in patients with ESR1 mutated tumors (HR, 0.55; 95% CI, 0.39-0.77; P = .0005).
  • The phase 2 ELCIN trial is evaluating the efficacy and safety of elacestrant in patients with ER+/HER2- metastatic breast cancer who received prior ET and no prior CDK4/6i in the metastatic setting.
  • The trial will include 60 patients, with recruitment ongoing worldwide.
  • Elacestrant is associated with a manageable safety profile, making it a promising treatment option for patients with ER+/HER2- metastatic breast cancer.
  • Preclinical studies demonstrated that elacestrant is equally active in both in vitro and in vivo models of ER+/HER2- breast cancer, regardless of prior exposure to CDK4/6i.

Statistics:

  • 30% reduced risk of progression or death in the overall population (HR, 0.70; 95% CI, 0.55-0.88; P = .002)
  • 45% reduced risk of progression or death in patients with ESR1 mutated tumors (HR, 0.55; 95% CI, 0.39-0.77; P = .0005)
  • 60 patients planned for enrollment in the ELCIN trial
  • Recruitment ongoing worldwide

Sources:

  • EMERALD trial (NCT03778931)
  • ELCIN trial (NCT05596409)
  • MJH Life Sciences (2025). All rights reserved.