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Life sciences · Phase 3 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 3 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 (NCT05038735). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 210 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: Alpelisib; DRUG: Fulvestrant; DRUG: Alpelisib-matching placebo. Primary outcome measures: Progression-free survival (PFS) based on BIRC assessments and using RECIST v1.1 criteria , From randomization to date of the first documented progression or death due to any cause, assessed up to a maximum duration of 60 months.. Brief summary: The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.