NCT00897884已完成不适用
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- To determine if taking metformin prior to surgery can reduce cell proliferation rates in tumour tissue. To be determined by tumour specimen analysis using pre- and post-operative biopsy sample.
研究概览
简要总结
The study will be testing metformin in patients with breast cancer who are about to undergo surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their surgery date. It is hypothesized that metformin will reduce cell proliferation rates in tumour tissue.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •invasive T1-4 (if T1, ≥ 1cm), NX operable breast cancer confirmed on core biopsy
- •< 70 years of age
- •breast surgery scheduled at least 2 weeks after study entry at one of the participating institutions (metformin will be started no more than 3 weeks prior to scheduled surgery) for the current breast cancer
- •patient and physician consent
排除标准
- •on metformin for any reason during the preceding 4 weeks
- •recent (within 4 weeks) antiestrogen or estrogen therapy
- •prior or concurrent systemic neoadjuvant BC therapy of any type (chemotherapy, hormone therapy, biologic therapy)
- •known diabetes or baseline fasting glucose > or = 7.0 mmol/L (specific treatment is required)
- •current or recent (within 4 weeks) use of drugs that may influence insulin or insulin sensitivity including oral corticosteroids, insulin sensitizers, exogenous insulin or oral hypoglycemic agents
- •serum creatinine above upper limit of normal for the institution
- •history of lactic or other metabolic acidosis
- •consumption of > 3 alcoholic beverages per day (on average)
- •AST > 1.5 times upper limit of normal for the institution
- •known hypersensitivity or allergy to metformin
- •current or past congestive heart failure
- •coagulopathy (including use of anti-coagulants) precluding biopsy
- •pregnancy or lactation within 3 months.
- •Serious psychiatric illness
- •Note: Women with childbearing potential will be required to use an effective form of birth control (condom or other barrier method, tubal ligation or vasectomy - oral contraceptives are contra-indicated in breast cancer) and to have a negative pregnancy test prior to starting metformin.
研究组 & 干预措施
Metformin
Experimental
Patients will take metformin three times a day for two to three weeks prior surgery.
干预措施: Metformin (Drug)
结局指标
主要结局
To determine if taking metformin prior to surgery can reduce cell proliferation rates in tumour tissue. To be determined by tumour specimen analysis using pre- and post-operative biopsy sample.
时间窗: two to three weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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