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

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05753657
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 60.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer; Hyperinsulinism; Hyperglycemia Drug Induced	Drug: Pioglitazone	Early Phase 1

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Dec 25, 2022
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer	Drug: Pioglitazone; hyperinsulinemia and hyperglycemia

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. Progression free survival in patients enrolled in the study and in patients treated per protocol [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel	3109601

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Ayelet Shai, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ayelet Shai MD, Head of breast cancer unit, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT05753657
• Other Study ID Numbers: 0494-22-RMB
• First Posted: Mar 3, 2023
• Last Update Posted: Mar 3, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Hyperglycemia; Hyperinsulinism; Pioglitazone

Study Results

No Results Posted as of Mar 3, 2023