EUCTR2007-000306-70-GB进行中（未招募）1 期
The effect of metformin on biomarker activity in primary breast cancer - NeoMet Trial
niversity of Dundee0 个研究点目标入组 55 人开始时间: 2007年4月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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
入选标准
- •1. Women able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy (see appendix 1: Preparation of core biopsies), with >30% positive malignant epithelial cells on histology, and identified = 1cm tumors on ultrasound and/ or mammography.
- •2. Tumour measurable by clinical examination, mammography and ultrasound.
- •3. Adequate bone marrow function as shown by: WBC =3.5 x 109/L, ANC =1.5 x 109/L, Platelets =100, Hb >10g/ dl
- •4. Adequate liver function as shown by: serum bilirubin = 1.5 x ULN, albumin = 3g/dl, serum transaminases activity = 2.5 x ULN, alkaline phosphatase = 2.5 x ULN
- •5. Normal renal function (serum creatinine = 1.5 x ULN, BUN 1.5 x ULN)
- •6. A life expectancy of at least 6 months
- •7. 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
- •1. Any degree of renal impairment, measured by serum creatinine = 1.5 x ULN, BUN 1.5 x ULN
- •2. Known diabetic patients
- •4. Respiratory failure
- •5. Liver failure
- •6. Use of iodine-containing X-ray contrast media in the past 2 days.
- •7. Patients likely to be considered to neo-adjuvant chemotherapy
- •8. Patients who may require staging involving a contrast CT scan
- •9. Patients with unstable angina, uncontrolled cardiac disease, or recent myocardial infarction (last 6 months)
- •10. Evidence of distant metastasis
- •11. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/ biological response modifiers (BRM’s), or radiotherapy.
- •12. Other investigational drugs within the past 30 days or the concomitant use of investigational drugs,
- •13. History of non-compliance to medical regimens and patients who are considered potentially unreliable
- •14. Drugs in the same class, or likely to affect the LKB1/ AMPK/ mTOR pathway
研究者
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