EUCTR2007-007161-20-BG进行中（未招募）不适用
Comparable efficacy and safety profiles of daily injection of BK0023 and filgrastim (Neupogen®) in chemotherapy-induced neutropenia: a multinational, multicenter, investigator blind, randomised, parallel group study in women with breast cancer
BIO-KER S.R.0 个研究点目标入组 288 人开始时间: 2008年12月30日最近更新:
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
- 288
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
- •Women aged =18 years
- •Subjects willing and able to give written informed consent
- •Diagnosis of high-risk stage II or stage III/IV breast cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •Subjects chemotherapy naïve or adjuvant therapy only and/or only one chemotherapy regimen for metastatic disease
- •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
- •Absolute neutrophil count < 1.5 x109/L; platelet count < 100 x109/L and
- •haemoglobin < 10 g/dl
- •Received systemic anti-infective treatment within 72h of chemotherapy
- •Prior bone marrow or stem cell transplantation
- •Total lifetime exposure to doxorubicin > 240 mg/m2 or epirubicin > 600
- •Subject of child bearing potential is evidently pregnant (eg, positive HCG
- •test) or is breast feeding
- •Subject of child bearing potential or partner of subject is not using or
- •refuses to use adequate contraceptive precautions
- •Previous exposure to G-CSF
研究者
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