# 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

> **NCT04208178** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 19 (actual)

## Conditions studied

- Advanced HER2+Breast Cancer

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Alpelisib matching Placebo
- **DRUG:** Trastuzumab
- **DRUG:** Pertuzumab

## Key facts

- **NCT ID:** NCT04208178
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-07-16
- **Primary completion:** 2027-02-26
- **Final completion:** 2027-02-26
- **Target enrollment:** 19 (ACTUAL)
- **Last updated:** 2026-04-02


## Primary source

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

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04208178, "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". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT04208178. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*