A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Contact Information
Primary
Ayelet Shai, MD
a_shai@rambam.health.gov.il
+972-4-777-6700
Time Frame
Start Date: 2022-12-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Treatment arm
treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer
Related Therapeutic Areas
Sponsors
Leads: Rambam Health Care Campus