A Phase II Study of Ribociclib and Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study) (HCRN-BRE20-468)
Objective
Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC).
Secondary Objectives: To estimate distant metastasis-free survival. To estimate overall survival (OS). To evaluate safety and tolerability. To identify predictors of loco-regional recurrence.
