Breast Cancer
Conditions
Interventions
Group 1:Jinyouli (PEG-rhG-CSF) was injected subcutaneously 48 hours after the end of chemotherapy
Group 2:Jinyouli (PEG-rhG-CSF) was injected subcutaneously 24 hours after the end of chemotherapy
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years old; (2) Invasive breast cancer diagnosed by histopathology; (3) Adjuvant chemotherapy is required for clinical stage I-III; (4) plan to receive AC or EC chemotherapy; (5) ECOG= 2; (6) has not received chemotherapy before; (7) There were no obvious signs of hematological diseases. Before enrollment, ANC =1.5×10^9/L, platelet count=100×10^9/L, Hb=90g/L, WBC=3.0×10^9/L, and no bleeding tendency; (8) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) There are currently uncontrollable infections; or systemic antibiotics are received within 72 hours of receiving chemotherapy; (2) The previous malignant tumors were not cured; (3) Liver function tests Total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal; (4) renal function test: serum creatinine (Cr) > 1.5 times the upper limit of normal; (5) Those who are allergic to this product or other genetically engineered E. coli-derived biological products; (6) Female patients during pregnancy or lactation; women of childbearing age who refuse to receive contraception; (7) The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Test group and control group: incidence of febrile neutropenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Test group and control group: The incidence of III/IV ANC reduction;Test group and control group: The incidence of chemotherapy dosage adjustment or delayed chemotherapy;Proportion of patients receiving antibiotic treatment during chemotherapy;Test group and control group:RDI; | — |
Countries
China
Contacts
Public ContactGeng Cuizhi
The Fourth Hospital of Hebei Medical University
Outcome results
None listed