A Phase II Randomized Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Chinese Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, PIK3CA Mutant Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment, Including a Subset With Pharmacokinetic Analysis
Latest Information Update: 09 May 2024
At a glance
- Drugs Alpelisib (Primary) ; Fulvestrant (Primary)
- Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
- Focus Therapeutic Use
- Sponsors Novartis Pharmaceuticals
- 04 May 2024 Planned End Date changed from 24 Jun 2028 to 28 Feb 2025.
- 04 May 2024 Planned primary completion date changed from 23 Jan 2026 to 28 Feb 2025.
- 14 Mar 2024 Status changed from recruiting to active, no longer recruiting.