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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.
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Registry record from ClinicalTrials.gov (NCT04544189). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 69 participants (ACTUAL). Conditions: Breast Neoplasms. Interventions: DRUG: Alpelisib; DRUG: Fulvestrant; DRUG: Placebo. Primary outcome measures: Progression Free Survival (PFS) , From the date of randomization to the date of the first documented progression or death due to any cause, up to approximately 34 months. Brief summary: The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant. The primary scientific question of interest is: what is the treatment effect based on PFS for alpelisib in combination with fulvestrant versus placebo in combination with fulvestrant in Chinese men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who received prior treatment with an aromatase inhibitor (AI) either as (neo) adjuvant treatment or as treatment for advanced disease, regardless of study treatment discontinuation or start of new anti-neoplastic therapy.