drugset / Trial / NCT04899349
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
RandomizedParallel-groupOpen-labelPrevention
Summary
This study was designed to assess the safety and efficacy of the combination of dapagliflozin plus metformin extended release (XR) compared with metformin XR during treatment with alpelisib plus fulvestrant in participants with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor-2 (HER2)-negative advanced breast cancer with a Phosphoinositide-3-Kinase Catalytic subunit Alpha (PIK3CA) mutation following progression on or after endocrine-based therapy.
Timeline
- Start
- 2022-04-06
- Primary completion
- 2023-05-10
- Completion
- 2023-05-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | — |
| Subject | Metformin | Small molecule | 2000 mg | — |
| Background | Alpelisib | Small molecule | 300 mg | — |
| Background | Fulvestrant | Small molecule | 500 mg | — |