A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Recruiting
Early Phase 1
Interventional Study
Metastatic Breast Cancer
Hyperinsulinism
Hyperglycemia Drug Induced
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Female
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Rambam Health Care Campus · Other
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About This Trial
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 Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant.
* Ages 18 - 85
* ECOG performance status 0, 1 or 2
* Ability to understand and willingness to sign a written …
Contacts