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Breast Cancer Stage Iv / Metastatic Breast Cancer / Alpelisib · Phase 2 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a Phase 2 interventional trial, not a published results report. The study is designed to explore whether ketogenic diet, low-carbohydrate diet, or canagliflozin can prevent hyperglycemia in patients receiving alpelisib and fulvestrant for PIK3CA-mutant metastatic breast cancer. No efficacy, safety, or outcome data are reported in this registry entry.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer; age from 18 Years. Intervention: Ketogenic Diet; Low Carbohydrate Diet; SGLT2i Therapy. n = 15. 9 sites: United States.
This is a registry record for a Phase 2 interventional trial, not a published results report. The study is designed to explore whether ketogenic diet, low-carbohydrate diet, or canagliflozin can prevent hyperglycemia in patients receiving alpelisib and fulvestrant for PIK3CA-mutant metastatic breast cancer. No efficacy, safety, or outcome data are reported in this registry entry.
Primary outcome is a surrogate (hyperglycemia-free rate); clinical benefit, cancer efficacy, and safety outcomes are not specified.
Results from this trial, when published, may inform strategies to manage hyperglycemia as a side effect of alpelisib therapy in metastatic breast cancer. The small sample size limits the ability to draw definitive conclusions about efficacy or comparative effectiveness of dietary versus pharmacological approaches.
Early-phase, single-centre Phase 2 interventional study with small planned enrollment (n=15) examining a surrogate endpoint (hyperglycemia-free rate) in an exploratory design; results not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial, when published, may inform strategies to manage hyperglycemia as a side effect of alpelisib therapy in metastatic breast cancer. The small sample size limits the ability to draw definitive conclusions about efficacy or comparative effectiveness of dietary versus pharmacological approaches.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05090358). This is a study registration, not published results. Lead sponsor: Memorial Sloan Kettering Cancer Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 15 participants (ACTUAL). Conditions: Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer. Interventions: DIETARY_SUPPLEMENT: Ketogenic Diet; DIETARY_SUPPLEMENT: Low Carbohydrate Diet; DRUG: Alpelisib; DRUG: Fulvestrant; DRUG: Canagliflozin. Primary outcome measures: Hyperglycemia-free rate for participants , 12 weeks. Brief summary: The purpose of this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the study drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer therapy in people who are receiving standard treatment with alpelisib and fulvestrant for their metastatic PIK3CA-mutant breast cancer.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.