A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Ribociclib with Endocrine Therapy As An Adjuvant Treatment In Patients with Hormone Receptor-Positive, HER2-Negative, High Risk Early Breast...
To compare iDFS for ribociclib + ET versus placebo + ET in patients with HR-positive, HER2-negative, high-risk EBC.
To evaluate the two treatment groups with respect to recurrence-free survival
To evaluate the two treatment groups with respect to distant disease-free survival (DDFS)
To evaluate the two treatment groups with respect to overall survival (OS)
To evaluate patients reported outcomes for health-related quality of life in the two treatment groups
To evaluate safety and tolerability of the treatment regimen