Overview
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Status:
Terminated
Terminated
Trial end date:
2018-05-23
2018-05-23
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Avera McKennan Hospital & University Health CenterTreatments:
Doxorubicin
Liposomal doxorubicin
Metformin
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