Clinical Trial

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node -positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence – A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)(STML-ELA-0422)

MOA: Elacestrant is an oral SERD and ER antagonist.

Key Eligibility Criteria:

• Women or men with confirmed ER-positive (≥10% by IHC), HER2-negative [IHC = 0 or 1, or (IHC = 2 and ISH-negative)] early stage resected BC without evidence of recurrence or distant metastases
  • Pts should be between 2 to 6 years from the date of curative surgical resection
• Pts should have received ≥24 mo and <60 mo of ET(AIs or tamoxifen) with/without a CDK4/6i and with/without an LHRH agonist
  • Pts who received prior CDK4/6i or PARP inhibitor must have already completed or discontinued these treatments
• Pt must be considered candidate for additional 5 years of ET
• Pts considered at high risk of recurrence at pathologic staging
  • ≥ 4 positive axillary lymph nodes or
  • 1-3 positive axillary lymph nodes and
    • Histologic grade 3 disease or
    • Tumor size ≥ 5 cm.
• Male pts receiving AI or elacestrant must receive an LHRH agonist