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:


  • Decision:


  • Meeting Date:


  • Study Type:

    CT application

  • Principal Investigator:

    Janice Walshe

  • PI Institution:

    Cork University Hospital

  • Sponsor:

    Novartis Pharma AG

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