CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 416 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Paclitaxel 80 mg/m2from 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/NCT01572727
NCT01572727Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

Novartis Pharmaceuticals·interventional·Posted Apr 6, 2012·Updated Mar 9, 2017

In Brief

A Phase 3 clinical trial evaluating Paclitaxel, BKM120 matching placebo, and 1 other intervention for Breast Cancer. Completed, enrolled 416 participants across 112 sites in 22 countries.

Detailed Summary

This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.2 years ago

Interventions

Paclitaxeldrug

intravenous paclitaxel 80 mg/m2 per week given until progression

BKM120 matching placebodrug

Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

BKM120drug

Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.