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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 18, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07679269). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 51 participants (ESTIMATED). Conditions: 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. Primary outcome measures: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) , From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months. Brief summary: 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.