Neutropenia
Conditions
Interventions
Group 2:rhG-CSF
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years; 2. Histopathological diagnosis breast cancer patients require adjuvant chemotherapy and are suitable for chemotherapy with epirubicin + cyclophosphamide sequential bi-weekly paclitaxel (EC-T) regimen; 3. ECOG PS =1; 4. expected survival time = 6 months; 5. Suitable for chemotherapy: WBC=4.0 × 10^9/L; ANC=2.0 × 10^9/L; PLT=100 ×10^9/L, No bleeding tendency; 6. Electrocardiogram examination showed no obvious abnormality, no obvious cardiac dysfunction, and left ventricular ejection fraction was normal; 7. Liver function: ALTTBILAST=2.5 ULN; 8. Renal function: Cr, BUN = 1.5 ULN; 9. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The total amount of doxorubicin used in previous chemotherapy was > 240mg /m2 or epirubicin> 360mg/m2; 2. accepted stem cell or bone marrow transplant; 3. attending any other clinical trial; 4. uncontrolled infection, temperature=38 degree C; 5. received PEG-rhG-CSF before enrollment; 6. received chemotherapy within 4 weeks before enrollment; 7. patients with any organ metastasis; 8. severe and uncontrolled diabetes; 9. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products; 10. Suspected or confirmed drug use, drug abuse, alcoholics; 11. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation; 12. Severe heart, kidney, liver and other important organs chronic diseases; 13. Pregnancy or lactation in women or women with gestation detection positive before the first time using drug; 14. Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of febrile neutropenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of grade 3 and 4 neutropenia;Incidence of grade 3 and 4 neutropenia; | — |
Countries
China
Contacts
Public ContactErwei Song, Qiang Liu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed