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

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.

NCT Number	NCT07679269
Lead Sponsor	Novartis Pharmaceuticals
Conditions	PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
Enrollment	51 participants
Start Date	2027-01-01
Primary Completion	2031-06-27 (estimated)
Study Completion	2031-07-25 (estimated)
Updated on ClinicalTrials.gov	2026-07-01