Monitoring insulin levels and treating high insulin and blood sugar in breast cancer patients using pioglitazone.
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
This study is testing if using pioglitazone to manage insulin and blood sugar levels can help women with metastatic breast cancer who are being treated with Alpelisib.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Trial ID | NCT05753657 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and safety of monitoring insulin and glucose levels in patients with metastatic breast cancer who are being treated with Alpelisib. It will investigate the use of pioglitazone to manage hyperglycemia and hyperinsulinemia in these patients. The study will also assess the rates of glycemic control, treatment discontinuation, dose reductions, and progression-free survival associated with this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with ER positive HER2 negative metastatic breast cancer and a PIK3CA mutation, who are starting treatment with Alpelisib.
Not a fit: Patients with uncontrolled diabetes, gastrointestinal issues affecting drug absorption, or those allergic to pioglitazone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new management strategy for metabolic side effects in breast cancer patients undergoing treatment.
How similar studies have performed: While this approach is novel, similar studies have shown promise in managing metabolic side effects in cancer treatments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Haifa
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
Study contacts
- Principal investigator: Ayelet Shai, MD — Rambam Health Care Campus
- Study coordinator: Ayelet Shai, MD
- Email: a_shai@rambam.health.gov.il
- Phone: +972-4-777-6700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.