Actively Recruiting
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Led by Rambam Health Care Campus · Updated on 2023-03-03
30
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant
- Ages 18 to 85 years
- ECOG performance status 0, 1 or 2
- Ability to understand and willingness to sign a written informed consent
You will not qualify if you...
- Impairment of gastrointestinal function or disease that may significantly alter absorption of Alpelisib
- Uncontrolled diabetes mellitus, defined as HbA1c above 8%
- Diabetes mellitus controlled by insulin
- Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting study compliance
- Pregnancy
- Known allergy to pioglitazone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
Research Team
A
Ayelet Shai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here