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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 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 2 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04899349
The ClinicalTrials.gov registry entry for NCT04899349 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fulvestrant is the first listed.
NCT04899349 reports 0 study locations.
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.
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