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 Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns

Conditions

• Breast Cancer

Interventions

• DRUG: Alpelisib
• DRUG: Fulvestrant
• DRUG: Metformin XR
• DRUG: Dapagliflozin + metformin XR
• DRUG: Dapagliflozin

Sponsor

Novartis Pharmaceuticals