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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2024

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At a glance

  • Drugs Alpelisib (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms BioItaLEE
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 13 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 04 May 2023 Planned End Date changed from 1 Jul 2024 to 31 Jan 2024.
    • 04 May 2023 Planned primary completion date changed from 1 Jul 2024 to 31 Jan 2024.

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