Study on the Efficacy and Safety of 4.5mg Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- RDI for each EC chemotherapy
研究概览
简要总结
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology, whom should accept ddEC regimen.
- •Expected survival is greater than 6 months
- •Qualified for chemotherapy，WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L. With no bleeding tendency or systemic hematology disorder symptoms.
- •No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left ventricular ejection fraction.
- •Liver function, ALT and AST should less than 2.5 times of the upper limit.
- •Renal function, Cr and BUN should less than 1.5 times of the upper limit.
- •Subjects voluntarily participate in this study and sign informed consent.
排除标准
- •Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or epirubicin>360mg/m2
- •Has received hematopoietic stem cell transplantation or bone marrow transplantation
- •Other drugs are currently in clinical trials
- •There are currently hard-to-control infections, body temperature is higher than 38 degrees.
- •Received PEG-rhG-CSF treatment before enrollment
- •Received chemotherapy in 4 weeks before enrollment
- •Patients with any visceral metastasis
- •Patients with severe heart, kidney, liver or any other important organs chronic diseases
- •Patients with severe uncontrolled diabetes
- •Patients with allergic diseases, or allergies to this product or other biological products derived from genetically engineered e. coli
- •Suspected or real drug users, substance abusers, alcoholics
- •Pregnant or lactating women
- •Severe mental or neurological disorders that affect informed consent and adverse reactions described or observed
研究组 & 干预措施
PEG-rhG-CSF
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
RDI for each EC chemotherapy
时间窗: 60 days after the first chemotherapy
Ratio of actual dose intensity to standard dose intensity
Chemotherapeutic dose adjustment due to neutropenia
时间窗: 60 days after the first chemotherapy
percentage of dose decreasing due to neutropenia
overall completion rate of chemotherapy
时间窗: 60 days after the first chemotherapy
calculate the overall chemo-completion rate among all patients
次要结局
- Incidence of febrile neutropenia(60 days after the first chemotherapy)
- Incidence of Grade 3/4 ACN reduction(60 days after the first chemotherapy)
- Duration of Grade 3/4 ACN reduction(60 days after the first chemotherapy)
研究者
Tao OUYANG
chief of breast surgery
Peking University