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.

Trial Details

NCT ID
NCT05753657
Phase
EARLY_PHASE1
Sponsor
Rambam Health Care Campus
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Pioglitazone
Locations (sample)
  • Haifa, Israel|32.81303,34.99928

Key Eligibility Criteria

  • Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpeli…
  • Ages 18 - 85
  • ECOG performance status 0, 1 or 2
  • Ability to understand and willingness to sign a written informed consent.

For full eligibility, visit ClinicalTrials.gov.

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