A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment

Trial Profile

A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After CDK 4/6 Inhibitor Treatment

Recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Aug 2018

At a glance

  • Drugs Alpelisib (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary)
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms BYLieve
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 24 Jun 2018 Planned End Date changed from 20 Mar 2020 to 10 Apr 2020.
    • 24 Jun 2018 Planned primary completion date changed from 20 Mar 2020 to 10 Apr 2020.
    • 10 Jun 2018 Planned End Date changed from 27 Feb 2020 to 20 Mar 2020.
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