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

Starting soon · Phase 2

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

In brief

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Key facts

Study ID

NCT07679269

Run by

Novartis Pharmaceuticals

People needed

51

Starts

2027-01-01

Expected to finish

2031-07-25

Last updated by the study team

2026-07-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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