USO 24151

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)

Disease Types: Breast Cancer Research

Eligibility Requirements:

• 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 initial 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

Available at:

• Chesapeake
• Newport News (Port Warwick III)
• Norfolk (Brock Cancer Center)
• Virginia Beach (Princess Anne)
• Williamsburg