Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer

• Status: Terminated
• Trial end date: 2018-05-23
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avera McKennan Hospital & University Health Center
• Treatments: 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