# Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Source: https://onco.cc/trials/nct04208178/  
OnCo record `nct04208178` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Alpelisib, Trastuzumab and Pertuzumab in HER2-positive breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation is a phase 3 interventional study registered as NCT04208178 by Novartis Pharmaceuticals, with 19 participants enrolled, started 2020-07-16 and due to reach its primary completion in 2027-02-26. Interventions recorded: Alpelisib, Alpelisib matching Placebo, Trastuzumab and Pertuzumab.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04208178
- Phase: 3
- Setting: EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 19

## Sources

- ClinicalTrials.gov NCT04208178: https://clinicaltrials.gov/study/NCT04208178

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- drugs: [Alpelisib](https://onco.cc/drugs/alpelisib/), [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/)

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JSON: https://onco.cc/api/v1/entities/nct04208178.json