Chemotherapy-induced Neutropenia
Conditions
Keywords
Chemotherapy, Neutropenia, breast cancer
Brief summary
Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia
Detailed description
* 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
Interventions
DRUGrHSA-GCSF 2.4mg
Human Serum Albumin GCSF 2.4mg at day 3 and day 7
DRUGGCSF
GCSF 5 mcg/kg/day
Sponsors
Tianjin SinoBiotech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main curative effect evaluation index | 4 weeks | The duration of the degree of Ⅳ neutropenia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy evaluation index | 8 weeks | The duration of the degree of Ⅳ neutropenia(ANC\<0.5×109/L) |
| Secondary efficacy evaluation index-1 | 8 weeks | The time required for neutrophil recovery to 2.0x109/L( |
| Secondary efficacy evaluation index-2 | 8 weeks | ANC |
| Secondary efficacy evaluation index-3 | 8 weeks | febrile neutropenia |
| Secondary efficacy evaluation index-4 | 8 weeks | The usage of antibiotics |
Countries
China
Outcome results
None listed