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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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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2026

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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 Pharmacodynamics; Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms BioItaLEE
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 10 Jul 2026 Primary endpoint changed from ctDNA alterations over time to PFS based on mutational dynamics. Four additional primary endpoints (PFS events, hotspot-mutated genes, VAF, and PR) were added.
  • 10 Jul 2026 Status changed from completed to discontinued. Reason the study was stopped: Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint.
  • 13 Feb 2024 Status changed from active, no longer recruiting to completed.

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