drugset
drugset / Trial / NCT04251533

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

NCT04251533 ↗

Phase 3 Terminated 137 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Timeline

Start
2020-06-08
Primary completion
2023-05-31
Completion
2026-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 300 mg Oral
Background Paclitaxel Small molecule 100 mg/m2 Intravenous

Indications

triple-negative breast carcinoma