Study of Pioglitazone to Treat Insulin and Blood Sugar Issues in Women Using Alpelisib for Metastatic Breast Cancer

What this Trial Is About

This research aims to evaluate whether monitoring insulin levels and treating high insulin and blood sugar levels with the drug pioglitazone is feasible and safe in female patients receiving Alpelisib for metastatic breast cancer. The study focuses on women aged 18 to 85 with ER positive HER2 negative metastatic breast cancer who have a PIK3CA mutation. It also assesses how well this approach controls blood sugar, how often treatment doses are reduced or stopped, and how long patients live without cancer progression. Participants receive treatment with pioglitazone alongside Alpelisib and fulvestrant for their metastatic breast cancer. The study is an early phase 1 trial that follows patients as they receive this combined treatment, focusing on managing hyperinsulinemia and hyperglycemia induced by Alpelisib. The trial tracks treatment safety and feasibility while monitoring patient responses over an average of one year. Throughout the study, patients are regularly monitored for severe and all-grade hyperglycemia, insulin and glucose levels, and treatment side effects. Researchers also measure the progression-free survival of participants. Safety is carefully observed, including any dose adjustments or treatment discontinuations due to blood sugar issues. This monitoring helps evaluate the studys main outcomes and supports patient care during the trial period, which lasts about one year on average.

A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.