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: 07 Oct 2017

At a glance

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

    • 24 Aug 2017 Planned End Date changed from 31 Dec 2019 to 31 Jan 2020.
    • 24 Aug 2017 Planned primary completion date changed from 31 Dec 2019 to 31 Jan 2020.
    • 27 Jul 2017 Planned End Date changed from 1 Jan 2020 to 31 Dec 2019.
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