A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
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
Age
18–85
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
