Clinical trial
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
NCT04251533 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation
- Lead sponsor
- Novartis Pharmaceuticals
- Phase
- Phase 3
- Overall status
- Terminated
- Start date
- June 8, 2020
- Completion date
- February 5, 2026
- Enrollment
- 137 (actual)
- Sites
- 78
Conditions
As the registry lists them; a condition with its own page is linked.