Chemotherapy-induced Neutropenia
Conditions
Brief summary
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.
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. * 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.
Interventions
DRUGHSA-GCSF 1.2 mg
Human Serum Albumin GCSF 1.2mg at day 3 and Day 7
DRUGHSA-GCSF 1.5 mg
Human Serum Albumin GCSF 1.5 mg 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
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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. * ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency. * 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. * 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 |
|---|---|
| The mean of duration for class IV neutrophilic granulocytopenia | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The mean of duration for class IV neutrophilic granulocytopenia | 8 weeks |
| The mean of duration for ANC up to 2.0×109/L | 8 weeks |
| ANC | 8 weeks |
| The usage of antibiotics | 8 weeks |
| febrile neutropenia | 8 weeks |
Countries
China
Outcome results
None listed