Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- frequency of neutropenia
研究概览
简要总结
After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.
详细描述
The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy
排除标准
- •pregnancy,
- •cardiovascualr disease,
- •abnormal renal function,
- •hematologic disorder
研究组 & 干预措施
early injection
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
干预措施: late leukostim (Drug)
late injection
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
干预措施: early leukostim (Drug)
结局指标
主要结局
frequency of neutropenia
时间窗: Change from Baseline in neutrophil count at 21days
during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)
次要结局
未报告次要终点
研究者
Hyuk moon Kim
Assistant professor
Sunchonhang University