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

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

Outcome

Missed primary endpoint

Stopped (Enrollment): “The study was terminated following a strategic decision to halt recruitment due to persistently slow enrollment. This decision was not driven by any new or unexpected safety concerns.”

registry analysis (superiority test); Part A: Alpelisib + Nab-paclitaxel vs Part A: Placebo + Nab-paclitaxel; Hazard Ratio (HR) 1.49 (95% CI 0.92 to 2.41) NCT04251533 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	300 mg	Oral
Background	Nab-paclitaxel	Small molecule	100 mg/m2	Intravenous

Indications