Phase II Pre-Surgical Intervention Study for Evaluating the Effect of Metformin on Breast Cancer Proliferation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Tumor Proliferation in Tumor Specimens
研究概览
简要总结
The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.
详细描述
Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
- •Body mass index > 25
- •Age ≥ 21 years
- •No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
- •Signed informed consent
排除标准
- •History of diabetes mellitus requiring medical therapy
- •Treatment with other investigational drugs within 6 months of study entry
- •Significant renal impairment with a creatinine > 1.4 mg/dl
- •Other serious intercurrent medical illness
研究组 & 干预措施
Metformin
Women with newly diagnosed early invasive breast cancer will receive Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Tumor Proliferation in Tumor Specimens
时间窗: Baseline, up to 4 weeks
This outcome measure examines the changes in tumor proliferation as measured by the amount of Ki-67 protein in the tumor.
次要结局
未报告次要终点
研究者
Dawn L. Hershman
Associate Professor of Medicine & Epidemiology
Columbia University