A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.
* Ages 18 - 85
* ECOG performance status 0, 1 or 2
* Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria:
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib
* Uncontrolled diabetes mellitus, defined as HbA1c above 8%
* Diabetes mellitus controlled by insulin
* Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnancy
* Known allergy to pioglitazone
Primary outcome measure(s)
Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol — 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 — through study completion, an average of 1 year
Progression free survival in patients enrolled in the study and in patients treated per protocol — through study completion, an average of 1 year
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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