NCT02944604已完成4 期
The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy
Peking University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of chemotherapy delay
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-65 years old, gender no limited.
- •2.Breast cancer diagnosed by pathology.
- •3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.
- •4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10^9/L, PLT（Platelet）≥80×10^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.
- •5.KPS (Karnofsky performance status) score≥
- •6.Expected survival≥3 months.
- •7.Written informed consent are acquired.
排除标准
- •Severe or uncontrolled infection.
- •Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
- •Mental or nervous system disorders.
- •Severe heart, lung and central nervous system disorders.
- •Pregnant or lactating women.
- •TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） > 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
- •Cr（creatinine） >1.5×ULN.
研究组 & 干预措施
PEG-rhG-CSF
Experimental
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Incidence of chemotherapy delay
时间窗: 60 days after the first chemotherapy
次要结局
未报告次要终点
研究者
Tao OUYANG
Chairman of Breast Center
Peking University
研究点 (1)
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