Overview

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