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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether monitoring insulin levels and treating high insulin and blood sugar levels with the drug pioglitazone is feasible and safe in female patients receiving Alpelisib for metastatic breast cancer. The study focuses on women aged 18 to 85 with ER positive HER2 negative metastatic breast cancer who have a PIK3CA mutation. It also assesses how well this approach controls blood sugar, how often treatment doses are reduced or stopped, and how long patients live without cancer progression. Participants receive treatment with pioglitazone alongside Alpelisib and fulvestrant for their metastatic breast cancer. The study is an early phase 1 trial that follows patients as they receive this combined treatment, focusing on managing hyperinsulinemia and hyperglycemia induced by Alpelisib. The trial tracks treatment safety and feasibility while monitoring patient responses over an average of one year. Throughout the study, patients are regularly monitored for severe and all-grade hyperglycemia, insulin and glucose levels, and treatment side effects. Researchers also measure the progression-free survival of participants. Safety is carefully observed, including any dose adjustments or treatment discontinuations due to blood sugar issues. This monitoring helps evaluate the study's main outcomes and supports patient care during the trial period, which lasts about one year on average.
CONDITIONS
Brief 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 - 85
- 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 (GI) function or GI disease that may significantly alter the absorption of Alpelisib
- Uncontrolled diabetes mellitus, defined as HbA1c above 8%
- Diabetes mellitus controlled by insulin
- Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy
- Known allergy to pioglitazone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Through study completion, an average of 1 year
Participants receive pioglitazone to treat hyperinsulinemia and hyperglycemia while being treated with Alpelisib for metastatic breast cancer.
Trial Site Locations
Total: 1 location
1
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
Research Team
A
Ayelet Shai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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