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Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer

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ClinicalTrials.gov Identifier: NCT02472353
Recruitment Status : Terminated (did not meet target accrual)
First Posted : June 15, 2015
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Brief 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Tumors Drug: Metformin Drug: Doxorubicin Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients
Study Start Date : July 2014
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Standard of Care
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
Drug: Doxorubicin
Standard of care treatment with doxorubicin

Experimental: Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
Drug: Metformin
Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
Other Name: Glucophage

Drug: Doxorubicin
Standard of care treatment with doxorubicin




Primary Outcome Measures :
  1. Left ventricle ejection fraction [ Time Frame: 1 year ]
    Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).


Secondary Outcome Measures :
  1. Left ventricle ejection fraction [ Time Frame: 7 years ]
    Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).

  2. Troponin I [ Time Frame: Drawn within 2-3 days following doxorubicin infusion ]
    To explore whether Troponin I correlates with a change in cardiac function and activity of metformin.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472353


Locations
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United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Kirstin Williams, CNP Avera McKennan Hospital & University Health Center

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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT02472353     History of Changes
Other Study ID Numbers: AMEM-2014-MET001
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Keywords provided by Avera McKennan Hospital & University Health Center:
breast
cancer
doxorubicin
metformin
cardiotoxicity
ejection fraction
LVEF
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Metformin
Doxorubicin
Liposomal doxorubicin
Hypoglycemic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action