RecruitingEarly Phase 1NCT05753657

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


Sponsor

Rambam Health Care Campus

Enrollment

30 participants

Start Date

Dec 25, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring insulin and blood sugar levels in breast cancer patients taking alpelisib (a targeted cancer drug) and testing whether adding pioglitazone (a diabetes medication) can control high blood sugar — a common and often treatment-limiting side effect of alpelisib. **You may be eligible if...** - You have ER-positive, HER2-negative metastatic breast cancer - Your tumor has a PIK3CA mutation (a specific genetic change) - You are about to start treatment with alpelisib and fulvestrant - You are between 18 and 85 years old - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if...** - You have uncontrolled diabetes - You have serious gastrointestinal problems that would affect medication absorption - You have significant liver, kidney, or heart problems that could interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone

hyperinsulinemia and hyperglycemia


Locations(1)

Rambam Health Care Campus

Haifa, Israel

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NCT05753657


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