# 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

> **NCT04899349** · PHASE2 · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 2 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Fulvestrant
- **DRUG:** Metformin XR
- **DRUG:** Dapagliflozin + metformin XR
- **DRUG:** Dapagliflozin

## Key facts

- **NCT ID:** NCT04899349
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-04-06
- **Primary completion:** 2023-05-10
- **Final completion:** 2023-05-10
- **Target enrollment:** 2 (ACTUAL)
- **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
- **Last updated:** 2024-10-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04899349

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT04899349. Licensed CC0.

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