Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer (EarLEE-2)

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, intermediate 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, Intermediate Risk Early Breast Cancer
Estimated Enrollment: 4000
Anticipated Study Start Date: March 31, 2018
Estimated Study Completion Date: November 17, 2025
Estimated Primary Completion Date: November 17, 2025 (Final data collection date for primary outcome measure)

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