CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 572 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/NCT02437318
NCT02437318Phase 3Completed
CompareCT.gov

A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Novartis Pharmaceuticals·interventional·Posted May 7, 2015·Updated Feb 13, 2025

In Brief

A Phase 3 clinical trial evaluating Fulvestrant, Alpelisib, and 1 other intervention for Breast Cancer. Completed, enrolled 572 participants across 197 sites in 31 countries.

Detailed Summary

To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor-2 (HER2)-negative advanced breast cancer, who received prior treatment with an aromatase Inhibitor (AI) either as (neo)adjuvant or for advanced disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Peru, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartJul 23, 2015
Primary CompletionJun 12, 2018
Study CompletionJun 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

Fulvestrantdrug

500 mg of fulvestrant administered via intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle

Alpelisibdrug

300 mg of alpelisib tablets for oral use administered once daily

Placebodrug

300 mg of placebo tablets for oral use administered once daily