Back to resultsUse of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Primary Purpose
Breast Cancer, Breast Tumors
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
Doxorubicin
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring breast, cancer, doxorubicin, metformin, cardiotoxicity, ejection fraction, LVEF
Eligibility Criteria
Inclusion Criteria:
- Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin
- Complete metabolic panel demonstrating adequate organ functions as defined by the following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Age greater than or equal to 21 years
Exclusion Criteria:
- Known diabetes
- History of cardiac arrhythmias or symptomatic cardiac disease
- Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications
- Currently taking metformin and/or sulfonylureas
- Known hypersensitivity or intolerance to metformin
- Baseline ejection fraction of less than 50% measured by echocardiogram
- Known hypersensitivity to contrast used during echocardiogram
- Risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day)
- Pregnant or breast feeding
Sites / Locations
- Avera Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of Care
Metformin + Standard of Care
Arm Description
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Outcomes
Primary Outcome Measures
Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).
Secondary Outcome Measures
Full Information
NCT ID
NCT02472353
First Posted
June 9, 2015
Last Updated
September 26, 2019
Sponsor
Avera McKennan Hospital & University Health Center
1. Study Identification
Unique Protocol Identification Number
NCT02472353
Brief Title
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Official Title
A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
did not meet target accrual
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
May 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avera McKennan Hospital & University Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to determine if co-administration of metformin and doxorubicin in breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of patients who develop a significant change in left ventricle ejection fraction (LVEF).
Detailed Description
This is a randomized, open-label, phase II design pilot study in patients with breast cancer requiring neoadjuvant or adjuvant chemotherapy. Eligible patients will be equally randomized to either receive metformin plus standard of care therapy or standard of care therapy alone. Patients receiving metformin will continue drug until the doxorubicin-containing cycles are complete, unless unacceptable toxicity occurs or the patient decides to withdraw from the study. Both arms of the study will undergo echocardiograms with contrast at baseline, upon completion of doxorubicin-containing cycles (within 28 days of completion), and at the one-year and seven-year time points. Additionally biomarker labs will be obtained to explore if there is a correlation between change in cardiac activity and the activity of metformin. If willing, all enrolled patients will provide a sample of whole blood for further exploratory analysis. Symptoms reported during the study will be correlated with know single nucleotide polymorphisms (SNPs) found during an exploratory genomic analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Tumors
Keywords
breast, cancer, doxorubicin, metformin, cardiotoxicity, ejection fraction, LVEF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Arm Title
Metformin + Standard of Care
Arm Type
Experimental
Arm Description
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Standard of care treatment with doxorubicin
Primary Outcome Measure Information:
Title
Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
Description
Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin
Complete metabolic panel demonstrating adequate organ functions as defined by the following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than ULN
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Age greater than or equal to 21 years
Exclusion Criteria:
Known diabetes
History of cardiac arrhythmias or symptomatic cardiac disease
Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling cardiac medications
Currently taking metformin and/or sulfonylureas
Known hypersensitivity or intolerance to metformin
Baseline ejection fraction of less than 50% measured by echocardiogram
Known hypersensitivity to contrast used during echocardiogram
Risk factors associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more alcoholic beverages per day)
Pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstin Williams, CNP
Organizational Affiliation
Avera McKennan Hospital & University Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
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