Monitoring insulin levels and treating high insulin and blood sugar in breast cancer patients using pioglitazone.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.