The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.
1. To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer. 2. To assess the feasibility and safety of treatment with pioglitazone in these patients. 3. To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol. 4. To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol. 5. To assess the median progression free survival of patients treated according to this protocol
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
hyperinsulinemia and hyperglycemia
Rambam Health Care Campus
Haifa, Israel
RECRUITINGRate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
Time frame: through study completion, an average of 1 year
Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol
Time frame: through study completion, an average of 1 year
Progression free survival in patients enrolled in the study and in patients treated per protocol
Time frame: through study completion, an average of 1 year
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