CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 668 enrolled
Drug / intervention
Ribociclib +2 moredrug
Likely dose
Ribociclib 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01958021
NCT01958021Phase 3Completed
CompareCT.gov

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Novartis Pharmaceuticals·interventional·Posted Oct 8, 2013·Updated Mar 7, 2025

In Brief

A Phase 3 clinical trial evaluating Ribociclib, Letrozole, and 1 other intervention for Advanced, Metastatic Breast Cancer. Completed, enrolled 668 participants across 221 sites in 29 countries.

Detailed Summary

The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced, Metastatic Breast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Lebanon, Netherlands, Norway, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartDec 17, 2013
Primary CompletionJan 29, 2016
Study CompletionMar 16, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.7 years ago

Interventions

Ribociclibdrug

Ribociclib (600 mg, in three 200 mg hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.

Letrozoledrug

Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

Placebodrug

Placebo (hard gelatin capsules or tablets) was administered orally once daily on Days 1-21 of each 28-day cycle.