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NCT04899349 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT04899349: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT04899349 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04899349, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with severe hyperglycemia over the first eight weeks of alpelisib plus fulvestrant treatment. Severe hyperglycemia (Grade ≥ 3) is defined as any glucose laboratory values \> 250 milligram (mg)/ deciliter (dL) (\> 13.9 millimole (mmol)/ liter (L))
Interventions
- DRUG Fulvestrant
- DRUG Dapagliflozin
- DRUG Alpelisib
- DRUG Metformin XR
- DRUG Dapagliflozin + metformin XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2023-05-10 |
| Phase | Phase 2 |
Why NCT04899349 stopped before completion
NCT04899349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Fulvestrant is the first listed.
NCT04899349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04899349 about?
NCT04899349 is a clinical study titled "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". 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...
What is the current status of trial NCT04899349?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2022-04-06. Estimated completion is 2023-05-10.
What interventions are being tested in trial NCT04899349?
The interventions under investigation include: Fulvestrant (DRUG), Dapagliflozin (DRUG), Alpelisib (DRUG), Metformin XR (DRUG), Dapagliflozin + metformin XR (DRUG).
Who is sponsoring clinical trial NCT04899349?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04899349's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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