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Active Not Recruiting
NCT05090358
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
Conditions: Breast Cancer, Breast Cancer Stage IV, Metastatic Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
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.
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR positive is defined by ER status \>10% immunohistochemical (IHC) staining of any intensity. HER2 negativity is defined as the following as per the 2018 American Society of
Clinical Oncology and College of American Pathologists guidelines:
* IHC score of 0 or 1+ or
* Single-probe average HER2 copy number of \
Source: ClinicalTrials.gov (NCT05090358). StuddyBuddy aggregates publicly available trial information.
