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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Human Serum Albumin GCSF 2.4mg at day 3 and day 7
GCSF 5 mcg/kg/day
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Main curative effect evaluation index
The duration of the degree of Ⅳ neutropenia
Time frame: 4 weeks
Secondary efficacy evaluation index
The duration of the degree of Ⅳ neutropenia(ANC\<0.5×109/L)
Time frame: 8 weeks
Secondary efficacy evaluation index-1
The time required for neutrophil recovery to 2.0x109/L(
Time frame: 8 weeks
Secondary efficacy evaluation index-2
ANC
Time frame: 8 weeks
Secondary efficacy evaluation index-3
febrile neutropenia
Time frame: 8 weeks
Secondary efficacy evaluation index-4
The usage of antibiotics
Time frame: 8 weeks
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