A Phase II, Multicenter, Open-label, Two-cohort, Non-comparative 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 CDK 4/6 Inhibitor Treatment
Phase of Trial: Phase II
Latest Information Update: 13 Feb 2019
At a glance
- Drugs Alpelisib (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary)
- Indications Advanced breast cancer; Male breast cancer
- Focus Therapeutic Use
- Acronyms BYLieve
- Sponsors Novartis; Novartis Pharmaceuticals
- 28 Jan 2019 Planned End Date changed from 10 Apr 2020 to 27 Nov 2020.
- 20 Jan 2019 Planned number of patients changed from 160 to 336.
- 24 Jun 2018 Planned End Date changed from 20 Mar 2020 to 10 Apr 2020.