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
Stopped early · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04899349
- Run by
- Novartis Pharmaceuticals
- People needed
- 2
- Starts
- 2022-04-06
- Expected to finish
- 2023-05-10
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Washington Uni School of Med Siteman Cancer Center — St Louis, Missouri, United States
- Novartis Investigative Site — Kuala Lumpur, Malaysia
Full record on ClinicalTrials.gov
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