EUCTR2005-004126-56-GB进行中（未招募）不适用
Observational pharmacokinetic study of doxorubicin and cyclophosphamide in patients with early breast cancer. - AC PK Study
ewcastle upon Tyne Hospitals NHS Trust0 个研究点目标入组 50 人开始时间: 2006年2月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- All
入选标准
- •a)Aged 18 years or over.
- •b)Histological confirmation of primary breast cancer.
- •c)Written voluntary informed consent.
- •d)ECOG performance status of 0, 1, or 2[15] (see appendix 12.1).
- •e)Patients must have recovered from any major surgery effects, with a minimum of 2 weeks from time of surgery to drug administration.
- •f)Estimated life expectancy should be greater than 3 months.
- •g)Patients should have adequate haematological & biochemical parameters recorded within 2 weeks leading up to an anthracycline containing regimen administration, specifically:
- •Absolute neutrophil count > 1.0 x 109/L
- •Platelet count > 100 x 109/L
- •Haemoglobin > 9g/dL
- •Bilirubin < 1.5 x upper limit of normal (ULN)
- •AST/ALT < 2.5 x ULN
- •Alkaline phosphatase < 2.5 x ULN
- •Creatinine < 1.5 x ULN.
- •h)Women of childbearing potential should be practicing medically approved contraceptive precautions, in line with standard practice. There is no specific requirement for pregnancy testing.
- •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
- •a)Pregnancy or breastfeeding.
- •b)Patients with a history of another malignancy in the past 5 years with the exception of surgically cured basal cell cancer of the skin, cervical carcinoma in situ, or ductal (breast) carcinoma in situ.
- •c)Patients who have received prior radiotherapy or cytotoxic chemotherapy for any indication.
研究者
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