At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 340 enrolled
Drug / intervention
alpelisib +2 moredrug
Likely dose
Not stated in 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.
A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating alpelisib, buparlisib, and 1 other intervention for Breast Cancer. Completed, enrolled 340 participants across 86 sites in 17 countries.
Detailed Summary
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Germany, Hong Kong, Israel, Italy, Japan, Lebanon, Netherlands, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartMar 2014
Primary CompletionJul 2017
Study CompletionJul 2017
TodayJul 2026
First PostedAug 15, 2013
Enrollment StartMar 11, 2014
Primary CompletionJul 7, 2017
Study CompletionJul 8, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.9 years ago
Interventions
alpelisibdrug
BYL719 + Letrozole
buparlisibdrug
BKM120 + Letrozole
Placebodrug
Placebo (of BYL719 or BKM120) + Letrozole