A Phase 3 Study of elacestrant versus standard endocrine therapy in node-positive ER+, HER2- early breast cancer with high risk of recurrence (ELEGANT)

Posted on 05/14/2025

Despite advances in the adjuvant treatment of early-stage estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, there continues to be a risk of recurrence. The ELEGANT study is a Global, Multicenter, Randomized, Open-label Phase 3 Study with the primary goal to evaluate the efficacy and safety of elacestrant versus standard endocrine therapy in participants with node-positive ER+/HER2- early breast cancer with high risk of recurrence. The main purpose of this study is to compare the Invasive Breast Cancer-Free Survival (IBCFS) over a period of up to 5 years. 4220 participants will be included in this study around the world. Participants will have equal chance to be assigned to receive either of the treatment combinations.



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