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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 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-05-11

Study results available
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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)

Conditions

  • Triple Negative Breast Neoplasms

Interventions

DRUG

alpelisib

300 mg orally, once per day (QD), tablets

DRUG

placebo

300 mg orally, once per day (QD), tablets

DRUG

nab-paclitaxel

100 mg/m\^2 IV infusion, once per day (QD)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2023-05-31
Completion
2026-02-05
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • China
  • Colombia
  • Croatia
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Norway
  • Peru
  • Poland
  • Russia
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251533 on ClinicalTrials.gov