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
Price : $35 *
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
- 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.