CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 726 enrolled
Drug / intervention
Ribociclib +2 moredrug
Likely dose
Ribociclib 600mgfrom 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/NCT02422615
NCT02422615Phase 3Completed
CompareCT.gov

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

Novartis Pharmaceuticals·interventional·Posted Apr 21, 2015·Updated Nov 30, 2023

In Brief

A Phase 3 clinical trial evaluating Ribociclib, Fulvestrant, and 1 other intervention for Advanced Breast Cancer. Completed, enrolled 726 participants across 174 sites in 30 countries.

Detailed Summary

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Colombia, Czechia, Denmark, France, Germany, Hungary, Italy, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 21, 2015
Enrollment StartJun 9, 2015
Primary CompletionNov 3, 2017
Study CompletionJan 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.2 years ago

Interventions

Ribociclibdrug

Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.

Fulvestrantdrug

Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.

Placebodrug

Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.