Efficacy and Safety Phase IIb Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Main curative effect evaluation index
研究概览
简要总结
Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia
详细描述
- Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
- Targeted patients: breast cancer
- Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy
- Number of patients: 80
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed breast cancer, suitable for TEC or TE .
- •ECOG performance status 0 or
- •Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
- •No obvious abnormal ecg examination.
- •TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
- •Cr, BUN≤2.5×ULN.
- •Signed informed consent.
排除标准
- •Chemotherapy within past 4 weeks.
- •Uncontrolled inflammatory disease,axillary temperature≥38℃.
- •Merging other malignant tumor.
- •Pregnancy or nursing status.
- •Participation in another clinical trial with and investigational product within 3 months prior to study entry.
- •Severe diabetes mellitus, or poor blood sugar controller.
- •Allergic disease or allergic constitution. History of protein allergy.
- •History of drug addiction and alcoholism.
- •Hematopoietic stem cell transplantation or organ transplantation.
- •Antibiotics were treated within 72 hours before chemotherapy.
- •Long-term use of hormones or immunosuppressive agents.
- •Severe mental or neurological disease.
- •Chronic disease of severe cardiac, kidney and liver.
- •Other conditions that would be excluded from this study according to doctors'judgment.
研究组 & 干预措施
Test group
intervention: rHSA-GCSF 2.4 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.
干预措施: rHSA-GCSF 2.4mg (Drug)
Positive control group
intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.
TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.
Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days)
干预措施: GCSF (Drug)
结局指标
主要结局
Main curative effect evaluation index
时间窗: 4 weeks
The duration of the degree of Ⅳ neutropenia
次要结局
- Secondary efficacy evaluation index(8 weeks)
- Secondary efficacy evaluation index-1(8 weeks)
- Secondary efficacy evaluation index-2(8 weeks)
- Secondary efficacy evaluation index-3(8 weeks)
- Secondary efficacy evaluation index-4(8 weeks)