Dennis Slamon, Oleg Lipatov, Zbigniew Nowecki, Nicholas McAndrew, Bozena Kukielka-Budny, Daniil Stroyakovskiy, Denise A Yardley, Chiun-Sheng Huang, Peter A Fasching, John Crown, Aditya Bardia, Stephen Chia, Seock-Ah Im, Manuel Ruiz-Borrego, Sherene Loi, Binghe Xu, Sara Hurvitz, Carlos Barrios, Michael Untch, Rebecca Moroose, Frances Visco, Karen Afenjar, Rodrigo Fresco, Irene Severin, Yan Ji, Farhat Ghaznawi, Zheng Li, Juan P Zarate, Arunava Chakravartty, Tetiana Taran, Gabriel Hortobagyi
BACKGROUND: Ribociclib has been shown to have a significant overall survival benefit in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether this benefit in advanced breast cancer extends to early breast cancer is unclear. METHODS: In this international, open-label, randomized, phase 3 trial, we randomly assigned patients with HR-positive, HER2-negative early breast cancer in a 1:1 ratio to receive ribociclib (at a dose of 400 mg per day for 3 weeks, followed by 1 week off, for 3 years) plus a nonsteroidal aromatase inhibitor (NSAI; letrozole at a dose of 2...
March 21, 2024: New England Journal of Medicine