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A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)

Trial Profile

A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2019

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At a glance

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

    • 01 Aug 2019 Extension phase is added and treatment arm and title have been amended.
    • 23 May 2019 Planned End Date changed from 31 Oct 2021 to 30 Nov 2022.
    • 23 May 2019 Planned primary completion date changed from 31 Oct 2021 to 28 Dec 2020.
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