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Clinical trial

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

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Last updated:30th Mar 2018
Identifier: NCT03081234

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)

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

Category Value
Date last updated at source 2017-10-03
Study type(s) Interventional
Expected enrolment 4000
Study start date 2018-03-31
Estimated primary completion date 2025-11-17

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