Sioux Falls, South Dakota 57105


Purpose:

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).


Study summary:

This is a randomized, open-label, phase II design pilot study in patients with breast cancer requiring neoadjuvant or adjuvant chemotherapy. Eligible patients will be equally randomized to either receive metformin plus standard of care therapy or standard of care therapy alone. Patients receiving metformin will continue drug until the doxorubicin-containing cycles are complete, unless unacceptable toxicity occurs or the patient decides to withdraw from the study. Both arms of the study will undergo echocardiograms with contrast at baseline, upon completion of doxorubicin-containing cycles (within 28 days of completion), and at the one-year and seven-year time points. Additionally biomarker labs will be obtained to explore if there is a correlation between change in cardiac activity and the activity of metformin. If willing, all enrolled patients will provide a sample of whole blood for further exploratory analysis. Symptoms reported during the study will be correlated with know single nucleotide polymorphisms (SNPs) found during an exploratory genomic analysis.


Criteria:

Inclusion Criteria: - Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin - Complete metabolic panel demonstrating adequate organ functions as defined by the following: AST less than 2.5 times ULN; 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 - 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


NCT ID:

NCT02472353


Primary Contact:

Principal Investigator
Kirstin Williams, CNP
Avera McKennan Hospital & University Health Center

Kirstin Williams, CNP
Phone: 605-322-6900
Email: kirstin.williams@avera.org


Backup Contact:

Email: casey.williams@avera.org
Casey Williams, PharmD
Phone: 605-322-6900


Location Contact:

Sioux Falls, South Dakota 57105
United States

Kirstin Williams, CNP
Phone: 605-322-6900
Email: kirstin.williams@avera.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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