The Effect, Safety and Pharmacoeconomics of First or Second Level-prophylactic Use of PEG-rhG-CSF in Breast Cancer Patients With Medium-high Risk of Febrile Neutropenia During Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 主要终点
- FN rate
研究概览
简要总结
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
详细描述
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
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
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •provision of informed consent
- •stage I-III, invasive breast cancer
- •accept at least 4 cycles of chemotherapy
- •ECOG score 0-2
- •with medium-high risk of FN according to researchers
排除标准
- •accepted stem cell or bone marrow transplant
- •undergoing any other clinical trial
- •uncontrolled infection, temperature≥38℃
- •per-week scheme chemotherapy
- •concurrent with radiotherapy
- •allergic conditions
- •sever organ dysfunction
- •uncontrolled diabetes
研究组 & 干预措施
PEGCSF first level prophylactic use
The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy.
干预措施: PEGCSF first level prophylactic use (Drug)
PEGCSF second level prophylactic use
The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened.
干预措施: PEGCSF second level prophylactic use (Drug)
结局指标
主要结局
FN rate
时间窗: assessment at 1 month after the last cycle chemotherapy complete
rate of febrile neutropenia during all cycles of chemotherapy
次要结局
- FN-caused hospitalization(During all cycles of chemotherapy, through study completion, an average of half year)
- rate of 3-4 grade neutropenia(During all cycles of chemotherapy, through study completion, an average of half year)
- FN-caused antibiotic use rate(During all cycles of chemotherapy, through study completion, an average of half year)
- rate of dose reduction(During all cycles of chemotherapy, through study completion, an average of half year)