Breast cancer
Conditions
Interventions
Observation group:None
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged 18 to 75 years; 2.ECOG performance status score =4 cycles; 5.Judged by the investigator to have an indication for granulocyte colony-stimulating factor prophylaxis against neutropenia; 6.Expected survival >=3 months; 7.Able to comply with follow-up requirements; 8.No severe impairment of major organ function; 9.Understand and agree to comply with study procedures and methods, voluntarily participate in this study, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Severe organ dysfunction or diseases, including serious disorders and functional impairment of the heart, liver, kidney, pancreas, etc.; 2.Patients unable to tolerate subcutaneous injection of rhG-CSF-HSA; 3.Hypersensitivity to rhG-CSF-HSA or any excipient, with potential risk of anaphylactic shock; 4.Any physical or psychological disease or condition judged by the investigator that may increase trial risks, affect patient compliance with the protocol, or prevent the patient from completing the study; 5.Subjects with drug dependence, uncontrolled psychiatric disorders, or cognitive impairment; 6.Pregnant or lactating females, and fertile subjects unwilling to use contraceptive measures; 7.Participation in other similar clinical trials within the past 3 months; 8.Patients considered ineligible for enrollment by the investigator (e.g., those expected to discontinue treatment due to financial constraints, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chemotherapy discontinuation rate;Incidence of chemotherapy dose reduction;Incidence of febrile neutropenia (FN) per chemotherapy cycle;Duration of neutropenia and FN;Incidence of grade >=3 neutropenia (ANC <1.0×10^9/L) and grade 4 neutropenia (ANC <0.5×10^9/L) per cycle.;Quality of life score at 4 weeks post-treatment;Relative dose intensity;Incidence of chemotherapy delay; | — |
Countries
China
Contacts
Public ContactZuo Huaiquan
The affiliated hospital of southwest medical university
Outcome results
None listed