Clinical trial
EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor
NCT05038735 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor
- Lead sponsor
- Novartis Pharmaceuticals
- Phase
- Phase 3
- Overall status
- Active, not recruiting
- Start date
- December 17, 2021
- Completion date
- February 26, 2027
- Enrollment
- 210 (actual)
- Sites
- 68
Conditions
As the registry lists them; a condition with its own page is linked.
breast cancer