Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Stopped early · Phase 2
Conditions studied: Breast Cancer, Breast Tumors
In brief
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).
Key facts
- Study ID
- NCT02472353
- Run by
- Avera McKennan Hospital & University Health Center
- People needed
- 30
- Starts
- 2014-07-01
- Expected to finish
- 2018-05-23
- Last updated by the study team
- 2019-10-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Avera Cancer Institute — Sioux Falls, South Dakota, United States
Full record on ClinicalTrials.gov
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