A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

Metastatic Breast Cancer Clinical Trial

Official title:

A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753657
• Other study ID #: 0494-22-RMB
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 25, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Rambam Health Care Campus
• Contact: Ayelet Shai, MD
• Phone: +972-4-777-6700
• Email: a_shai[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer.

2. To assess the feasibility and safety of treatment with pioglitazone in these patients.

3. To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.

4. To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.

5. To assess the median progression free survival of patients treated according to this protocol

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Hyperglycemia
• Hyperglycemia Drug Induced
• Hyperinsulinism
• Metastatic Breast Cancer

Intervention

Drug:
• Pioglitazone
hyperinsulinemia and hyperglycemia

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol		through study completion, an average of 1 year
Primary	Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol		through study completion, an average of 1 year
Primary	Progression free survival in patients enrolled in the study and in patients treated per protocol		through study completion, an average of 1 year