Trial Identifiers
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Scientific Title
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Commercial Sponsor
Bristol-Myers Squibb (BMS)
Summary
Eligible patients will be randomised to receive Nivolumab OR Nivolumab-placebo in combination with Paclitaxel, followed by anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice.