CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 672 enrolled
Drug / intervention
Ribociclib +5 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/NCT02278120
NCT02278120Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Novartis Pharmaceuticals·interventional·Posted Oct 29, 2014·Updated Mar 12, 2024

In Brief

A Phase 3 clinical trial evaluating Ribociclib, Tamoxifen, and 4 other interventions for Advanced Metastatic Breast Cancer. Completed, enrolled 672 participants across 183 sites in 30 countries.

Detailed Summary

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Metastatic Breast Cancer
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Lebanon, Malaysia, Mexico, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 29, 2014
Enrollment StartNov 20, 2014
Primary CompletionAug 21, 2017
Study CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.7 years ago

Interventions

Ribociclibdrug

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

Tamoxifendrug

Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 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)

Anastrozoledrug

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

Goserelindrug

Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle

Placebodrug

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