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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