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RECRUITING
NCT05753657
EARLY_PHASE1

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

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-12-25

Completion Date

2027-12-31

Last Updated

2023-03-03

Healthy Volunteers

No

Interventions

DRUG

Pioglitazone

hyperinsulinemia and hyperglycemia

Locations (1)

Rambam Health Care Campus

Haifa, Israel