A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Launched by RAMBAM HEALTH CARE CAMPUS · Feb 22, 2023
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring whether monitoring insulin levels and treating high insulin and blood sugar levels with a medication called pioglitazone can be safe and effective for women with metastatic breast cancer who are receiving another treatment called Alpelisib. The study aims to find out how well this approach helps manage blood sugar levels and whether it affects the patients' overall health and response to cancer treatment.
To be eligible for this trial, participants must be women aged 18 to 85 with a specific type of metastatic breast cancer that has a certain genetic mutation. They should be planning to start treatment with Alpelisib and another medication called fulvestrant. Participants will be monitored closely throughout the study, and they will need to sign a consent form to join. It's important to note that women who are pregnant or have certain health conditions, such as uncontrolled diabetes or severe gastrointestinal issues, cannot participate. If you or a loved one is interested, this study provides a potential opportunity to help manage side effects related to cancer treatment.
Gender
FEMALE
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 informed consent.
- Exclusion Criteria:
- • 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
About Rambam Health Care Campus
Rambam Health Care Campus is a leading medical institution located in Haifa, Israel, renowned for its comprehensive patient care, advanced research initiatives, and commitment to medical education. As a prominent clinical trial sponsor, Rambam is dedicated to advancing healthcare through innovative research and development, facilitating a wide range of clinical studies across various therapeutic areas. The campus boasts state-of-the-art facilities, a multidisciplinary team of expert researchers and clinicians, and a robust infrastructure that supports rigorous scientific inquiry and ethical standards in clinical trials. By fostering collaboration and leveraging cutting-edge technology, Rambam Health Care Campus aims to enhance treatment options and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Haifa, , Israel
Haifa, Hatsafon, Israel
Patients applied
Trial Officials
Ayelet Shai, MD
Principal Investigator
Rambam Health Care Campus
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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