NCT05753657

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Metastatic Breast Cancer
• Hyperinsulinism
• Hyperglycemia Drug Induced

Interventions

Type	Name	Description
DRUG	Pioglitazone	hyperinsulinemia and hyperglycemia

Timeline

• Start date: 2022-12-25
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: Israel