EUCTR2008-004912-10-IT进行中（未招募）不适用
A pre-surgical phase II study on activity of Metformin on breast cancer cells proliferation. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Female, aged 18 years or older. Performance status = 0 (SWOG). Histologically-confirmed breast cancer, not suitable for neoadjuvant therapy. Stage T1-3, N0-1, Mx No previous treatment for breast cancer. Provision of written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous treatment for breast cancer, including chemotherapy and endocrine therapy. Known severe hypersensitivity to Metformin or any of the excipients of this product. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or in situ cervical cancer. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would prevent subjects from undergoing any of the treatment options or would prevent prolonged follow-up. Diabetes mellitus and diabetes? treatments Creatinine >1.5 mg/dl and/or Glomerular filtration > 60 ml/min/1.73m2 Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. Pregnancy or breast feeding (women of child-bearing potential must have a negative pregnancy test within 7 days before the start of study treatment and should practice acceptable methods of birth control to prevent pregnancy during and after study treatment). Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
研究者
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