Decision: Favourable
Study Title:
EPIK-B5: A Phase III, randomized, double-blind, placebocontrolled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HRpositive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor.
NREC Code:
21-NREC-CT-172
Decision:
Favourable
Meeting Date:
12/01/2022
Study Type:
CT application
Principal Investigator:
Janice Walshe
PI Institution:
Cork University Hospital
Sponsor:
Novartis Pharma AG