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

February 22, 2023 updated by: Ayelet Shai MD, Rambam Health Care Campus
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
Time Frame: through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Progression free survival in patients enrolled in the study and in patients treated per protocol
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2022

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0494-22-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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