Back to resultsA Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Primary Purpose
Metastatic Breast Cancer, Hyperinsulinism, Hyperglycemia Drug Induced
Status
Recruiting
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer
Outcomes
Primary Outcome Measures
Rate of severe (grade 3 and 4) hyperglycemia in patients enrolled in the study and in patients treated per protocol
Rate of all grade hyperglycemia in patients enrolled in the study and in patients treated per protocol
Progression free survival in patients enrolled in the study and in patients treated per protocol
Secondary Outcome Measures
Full Information
NCT ID
NCT05753657
First Posted
December 26, 2022
Last Updated
February 22, 2023
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT05753657
Brief Title
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
To assess the feasibility and safety of treatment with pioglitazone in these patients.
To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
To assess the median progression free survival of patients treated according to this protocol
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Hyperinsulinism, Hyperglycemia Drug Induced
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
hyperinsulinemia and hyperglycemia
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayelet Shai, MD
Phone
+972-4-777-6700
Email
a_shai@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayelet Shai, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayalet Shai, MD
Email
a_shai@rambam.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
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