Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

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

Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

• 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

Inclusion Criteria:

• Age 18-65.
• Diagnosed breast cancer, suitable for TEC or TE .
• ECOG performance status 0 or 1.
• 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.

Exclusion Criteria:

• 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.