Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer (NCT02472353) | Clinical Trial Compass
TerminatedPhase 2
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Stopped: did not meet target accrual
United States30 participantsStarted 2014-07
Plain-language 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).
Who can participate
Age range21 Years
SexALL
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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
What they're measuring
1
Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
Timeframe: 1 year
Trial details
NCT IDNCT02472353
SponsorAvera McKennan Hospital & University Health Center