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Clinical trial

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

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Last updated:19th Jun 2017
Identifier: NCT03078751

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)

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

Category Value
Date last updated at source 2017-11-08
Study type(s) Interventional
Expected enrolment 2000
Study start date 2017-06-20
Estimated primary completion date 2023-09-13

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