Live from ClinicalTrials.gov + Open Targets, fetched 2026-11-11 15:39 UTC. Every row links to its source record.
Postmortem · what the sponsor and named sources said, kept apart from what merely happened at the same time
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 · Novartis Pharmaceuticals · PHASE2 · terminated · last registry update 2024-10-09 · Breast cancer · Decision brief
No research has been run for this trial yet, so only the registry's own reason and the timeline are shown.
What was said, and by whom
Stated is the sponsor's own words; Reported is a named third party. The category is our label from a fixed list; the quote is the evidence.
| Kind | Quote | Our category | Source |
|---|---|---|---|
| Stated | “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” | – | Registry record, Novartis Pharmaceuticals |
Also happening at the time. Not shown to be a cause.
Registry events on other trials of drugs against PIK3CA in breast cancer within 12 months either side of this trial's last update, live from ClinicalTrials.gov. Nothing here was stated as a reason.
- 2025-10-01Also stopped (terminated): National Cancer Institute (NCI), Copanlisib + Pertuzumab (NCT04108858)
- 2025-07-28Results posted on the registry: National Cancer Institute (NCI), Copanlisib Hydrochloride + Eribulin Mesylate (NCT04345913)
- 2025-07-22Also stopped (terminated): Cancer Trials Ireland, Copanlisib + Trastuzumab emtansine (NCT04042051)
- 2025-05-31Results posted on the registry: Bryan Schneider, MD, Capecitabine + Talazoparib (NCT04849364)
- 2025-05-31Also stopped (terminated): Bryan Schneider, MD, Capecitabine + Talazoparib (NCT04849364)
- 2025-05-26Also stopped (terminated): Mayo Clinic, Belinostat + Carfilzomib (NCT03432741)
- 2025-04-10Results posted on the registry: Inova Health Care Services, Biopsy-Guided Therapy Selection (NCT04965688)
- 2025-04-10Also stopped (terminated): Inova Health Care Services, Biopsy-Guided Therapy Selection (NCT04965688)
- 2025-01-24Phase 3 first posted: Hoffmann-La Roche, Inavolisib + Placebo (NCT06790693)
- 2025-01-03Phase 3 first posted: Celcuity Inc, Arm A: Gedatolisib + Palbociclib + Fulvestrant + Arm B: Ribociclib + Fulvestrant (NCT06757634)
- 2024-12-09Results posted on the registry: Memorial Sloan Kettering Cancer Center, BYL719 + Letrozole (NCT01870505)
- 2024-10-09Results posted on the registry: Hoffmann-La Roche, Inavolisib + Placebo (NCT04191499)
- 2024-08-29Results posted on the registry: Memorial Sloan Kettering Cancer Center, Benralizumab + fulvestrant or AIs) and PI3K inhibition (alpelisib) (NCT05966584)
- 2024-08-29Also stopped (terminated): Memorial Sloan Kettering Cancer Center, Benralizumab + fulvestrant or AIs) and PI3K inhibition (alpelisib) (NCT05966584)
- 2024-07-31Results posted on the registry: Novartis Pharmaceuticals, alpelisib + placebo (NCT04251533)
- 2024-07-30Results posted on the registry: National Cancer Institute (NCI), Abemaciclib + Copanlisib Hydrochloride (NCT03939897)
- 2024-06-27Results posted on the registry: National Cancer Institute (NCI), Copanlisib + Pertuzumab (NCT04108858)
- 2024-06-20Also stopped (terminated): Novartis Pharmaceuticals, Alpelisib + Fulvestrant (NCT04862143)
- 2024-03-27Results posted on the registry: Novartis Pharmaceuticals, Alpelisib + Fulvestrant (NCT03056755)
- 2024-03-20Also stopped (withdrawn): National Cancer Institute (NCI), Alpelisib + Olaparib (NCT05967286)
- 2024-02-20Results posted on the registry: Novartis Pharmaceuticals, Alpelisib + Fulvestrant (NCT04862143)
What is not public
- Internal portfolio and board discussions
- Unpublished trial data and interim analyses
- Terms of any partner or licence decision