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BELLE-3: Buparlisib + Fulvestrant in HR+/HER2- Advanced Breast Cancer

NCT01633060Phase 3

Key facts

Status: Terminated
Start: Oct 2012
Primary completion: May 2016
Countries: 22
Sponsor: Novartis
Modality: Small Molecules

Drugs: buparlisib
Conditions: breast cancer

Overview

Phase 3, randomised, double-blind trial in breast cancer comparing BKM120 + Fulvestrant with Placebo + Fulvestrant (2 arms). Primary endpoint: Progression Free Survival up to 4 years. Started Oct 2012; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

BKM120 + Fulvestrant
Buparlisib 100 mg daily + Fulvestrant
Placebo + Fulvestrant
Placebo + Fulvestrant

Endpoints

Primary

Progression Free Survivalup to 4 years

Secondary

Overall Survivalup to 5 years
Progression Free Survival by PIK3CA Mutational Statusup to 5 years
Overall Survival by PIK3CA Mutational Statusup to 5 years
Overall Response Rateup to 5 years
Clinical Benefit RateWeek 24
Long-term Safety and Tolerabilityup to 5 years
Plasma Concentration-time ProfilesCycle 4 Day 1
Time to 10% Definitive Deterioration in Global Health Status/Quality of Lifeup to 5 years

Results

Primary endpoints met

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