Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer (NCT05090358) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
United States15 participantsStarted 2021-10-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<4 signals/cell or
* Dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of \<4 signals/cell or
* IHC 0, 1+, or 2+ and dual-probe HER2/CEP17 ratio ≥2 with an average HER2 copy number of \<4 signals/cell or
* IHC 0 or 1+ and dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of ≥6 signals/cell or
* IHC 0 or 1+ and dual-probe HER2/CEP17 ratio \<2 with an average HER2 copy number of ≥4 and \<6 signals/cell.
* Presence of one or more activating PIK3CA mutations in tumor tissue.
* Measurable or non-measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion must be present.
* Written informed consent provided
* Female or male ≥18 years of age
* Adequate archived tumor tissue for the analysis of PIK3CA mutational status or evaluable circulating tumor DNA (ctDNA) for analysis of PIK3CA mutation status
* Recurrence or progression of disease during or after endocrine-based therapy
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Life expectancy ≥6 months.
* Adequate organ and marrow functio…