# Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

> **NCT07679269** · PHASE2 · NOT_YET_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 51 (estimated)

## Conditions studied

- PIK3CA-Related Overgrowth Spectrum (PROS)
- Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Fulvestrant
- **DRUG:** Trastuzumab
- **DRUG:** Pertuzumab
- **DRUG:** Letrozole

## Key facts

- **NCT ID:** NCT07679269
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-12-15
- **Primary completion:** 2032-03-23
- **Final completion:** 2032-04-20
- **Target enrollment:** 51 (ESTIMATED)
- **Last updated:** 2026-09-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07679269

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07679269, "Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07679269. Licensed CC0.

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