Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients
Chemotherapy-induced Neutropenia, Cancer, Breast
About this trial
This is an interventional treatment trial for Chemotherapy-induced Neutropenia focused on measuring Neutropenia, Chemotherapy, rHSA/GCSF
Eligibility Criteria
Inclusion Criteria:
- Age 18-65.
- Diagnosed breast cancer,received chemotherapy.
- ECOG performance status 0 or 1.
- ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
- Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.
- No obvious abnormal ecg examination.
- Cr,TBIL, AST, ALT≤1.5×ULN,no serious underlying disease.
- 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.
- Received antibiotic treatment within 72 hours before chemotherapy.
- Long-term use of hormones or immunosuppressive agents.
- Severe mental or neurological disorders.
- Chronic disease of severe cardiac, kidney and liver.
- Other conditions that would be excluded from this study according to doctors'judgment.
Sites / Locations
- Chinese Academy of Medical Sciences Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
single injection-1.8mg
single injection-2.1mg
single injection-2.4mg
multiple injection-1.8mg
multiple injection-2.1mg
multiple injection-2.4mg
rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.