An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 3
- 主要终点
- The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim
研究概览
简要总结
The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 19 years old, and ≤ 64 years old, and
- •Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
- •Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia
排除标准
- •Patients with any of the followings are excluded.
- •Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
- •Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome
结局指标
主要结局
The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim
时间窗: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)
次要结局
- The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE(During the study period (~ 1months follow-up))