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: 02 Aug 2017
At a glance
- Drugs Alpelisib (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary)
- Indications Advanced breast cancer
- Focus Therapeutic Use
- Acronyms BYLieve
- Sponsors Novartis Pharmaceuticals
- 27 Jul 2017 Planned End Date changed from 1 Jan 2020 to 31 Dec 2019.
- 27 Jul 2017 Planned primary completion date changed from 15 Dec 2019 to 31 Dec 2019.
- 05 Jul 2017 Planned primary completion date changed from 1 Jan 2020 to 15 Dec 2019.