Chemotherapy-induced Neutropenia Clinical Trial
Official title:
Efficacy and Safety Phase II Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients
The purpose of this study is to evaluate the dosages of recombinant human serum
albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing
neutrophilic granulocytopenia among chemotherapy patients.
Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte
colony-stimulating factor fusion protein with recombinant human granulocyte
colony-stimulating factor injection as a control.
- 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.
- Positive control：recombinant human granulocyte colony-stimulating factor injection.
- Targeted patients: breast cancer
- Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating
factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum
albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment;
Group 3: positive control with TEC or TE treatment.
- Number of patients: 216
- Concomitant medicines will be conducted.
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