Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 51
Trial details
Phase: Phase 2Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Jul 1, 2026
Eligibility criteria

Written informed consent/assent, according to local guidelines, signed by the pa... [+3]

Participant had permanently discontinued from alpelisib in the parent study for... [+5]