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

NCT05753657 | Recruiting Early Phase 1

• 1 other identifier: 0494-22-RMB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer; Hyperinsulinism; Hyperglycemia Drug Induced

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Progression free survival in patients enrolled in the study and in patients treated per protocol

  through study completion, an average of 1 year

Study Arms (1)

Treatment arm

EXPERIMENTAL

treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

hyperinsulinemia and hyperglycemia

Treatment arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Hyperinsulinism

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ayelet Shai, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayelet Shai, MD

CONTACT

+972-4-777-6700; a_shai@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of breast cancer unit

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: March 3, 2023
• Study Start: December 25, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)