CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,147 enrolled
Drug / intervention
Fulvestrant +2 moredrug
Likely dose
Fulvestrant 500 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/NCT01610284
NCT01610284Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Novartis Pharmaceuticals·interventional·Posted Jun 4, 2012·Updated Aug 25, 2020

In Brief

A Phase 3 clinical trial evaluating Fulvestrant, BKM120, and 1 other intervention for Breast Cancer. Completed, enrolled 1,147 participants across 268 sites in 29 countries.

Detailed Summary

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2012
Enrollment StartAug 7, 2012
Primary CompletionApr 29, 2015
Study CompletionApr 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.1 years ago

Interventions

Fulvestrantdrug

Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)

BKM120drug

BKM120 100 mg once daily

BKM120 matching placebodrug

BKM120 matching placebo, once daily