Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1)

This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk breast cancer.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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 Cancer
Estimated Enrollment: 2000
Actual Study Start Date: June 20, 2017
Estimated Study Completion Date: September 13, 2023
Estimated Primary Completion Date: September 13, 2023 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Ribociclib + adjuvant endocrine therapy
- Active Comparator: Placebo + adjuvant endocrine therapy