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
Phase IITERMINATEDOPERATIONALConfidence: HIGH
Sponsor
Novartis Pharmaceuticals
Collaborators
Condition
Breast Cancer
Intervention
Alpelisib
Why 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
Provenance
Dataset: 2026-07-02 • Source: ClinicalTrials.gov API v2 • Last update: 2024-10-09