Overview

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

Status:
Recruiting

Trial end date:
2026-01-09

Target enrollment:

Participant gender:

Summary

The purpose of this study is 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)

Phase:

Phase 3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Albumin-Bound Paclitaxel
Paclitaxel