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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05753657
Study type Interventional
Source Rambam Health Care Campus
Contact Ayelet Shai, MD
Phone +972-4-777-6700
Email a_shai@rambam.health.gov.il
Status Recruiting
Phase Early Phase 1
Start date December 25, 2022
Completion date December 31, 2027

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