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BYLieve:A phase II, multicenter, open-label, three-cohort, noncomparative 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 prior treatments

Trial Profile

BYLieve:A phase II, multicenter, open-label, three-cohort, noncomparative 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 prior treatments

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Nov 2019

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At a glance

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

    • 07 Jul 2019 Planned End Date changed from 30 Sep 2020 to 30 Nov 2021.
    • 07 Jul 2019 Planned primary completion date changed from 10 Apr 2020 to 30 Nov 2020.
    • 01 Mar 2019 Planned End Date changed from 27 Nov 2020 to 30 Sep 2020.
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