Scientific Publications Database
Article Title: Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trialAuthors: Sonke, Gabe S.; Hart, Lowell L.; Campone, Mario; Erdkamp, Frans; Janni, Wolfgang; Verma, Sunil; Villanueva, Cristian; Jakobsen, Erik; Alba, Emilio; Wist, Erik; Favret, Anne M.; Bachelot, Thomas; Hegg, Roberto; Wheatley-Price, Paul; Souami, Farida; Sutradhar, Santosh; Miller, Michelle; Germa, Caroline; Burris, Howard A.
Journal: BREAST CANCER RESEARCH AND TREATMENT Volume 167 Issue 3
Date of Publication:2018
Abstract:
Purpose Determine the efficacy and safety of first-line ribociclib plus letrozole in elderly patients with HR+, HER2- advanced breast cancer.Methods 668 postmenopausal women with HR+, HER2- advanced breast cancer and no prior systemic therapy for advanced disease were enrolled in the Phase III MONALEESA-2 trial (NCT01958021); 295 patients were aged >= 65 years. Patients were randomized to ribociclib (600 mg/day; 3-weeks-on/1-week-off) plus letrozole (2.5 mg/day) or placebo plus letrozole until disease progression, unacceptable toxicity, death, or treatment discontinuation. The primary endpoint was PFS, which was evaluated in elderly (ae