A Phase II Pilot Study Using Metformin to Reduce Cardiac Toxicity in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care
Patients will receive standard of care for their breast cancer with no metformin during their treatment with doxorubicin.
干预措施: Doxorubicin (Drug)
Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
干预措施: Metformin (Drug)
Metformin + Standard of Care
Patients will receive metformin during their treatment with doxorubicin for their breast cancer.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram
时间窗: 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).
次要结局
未报告次要终点