Breast Cancer
Conditions
Interventions
Experimental Group:Administer a single fixed subcutaneous dose of 6 mg at 24–48 h after the completion of chemotherapy in each cycle.
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary invasive breast cancer diagnosed by histological pathology and clinical stage I-IIIC. 2. Age 18-70 years old 3. Weight >=45kg 4. ECOG physical fitness: 0~1 points 5. Expected to complete 8 cycles of ddEC-ddT neoadjuvant or adjuvant chemotherapy regimen according to schedule 6. Normal major organ function, meeting the following criteria 6.1. Normal bone marrow haematopoietic function, no bleeding tendency (INR=80g/L 6.2.2.WBC>=3.0×10^9/ L 6.2.3. ANC>=1.5×10^9/ L 6.2.4. PLT>=80×10^9/L 6.3. Liver function and biochemical tests need to meet the following criteria: 6.3.1. ALT and AST <= 2.5×ULN 6.3.2. TBIL<=1.5×ULN 6.3.3. blood creatinine <= 1.5 x ULN 6.4 No significant cardiac dysfunction 7. women of childbearing potential must have had a negative pregnancy test (serum or urine) within 7 days prior to enrolment and be willing to use an appropriate method of contraception during the trial period 8. be able to comply with the trial protocol as determined by the investigator 9. Volunteer to participate in this clinical trial, understand the study procedures and be able to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with a history of previous bone marrow transplantation and/or stem cell transplantation 2. Those with acute or active infections who have received systemic anti-infective treatment within 72h 3. Have other haematological disorders affecting bone marrow haematopoiesis 4. Serious concomitant diseases that, in the judgement of the investigator, jeopardise the patient's safety or affect the patient's ability to complete the study 5. Pregnant or lactating women 6. Participation in a clinical trial of another drug within 4 weeks prior to enrolment. 7. Previously treated with PEG-rhG-CSF 8. Hypersensitivity to the study drug or other biological products (PEG-rhG-CSF, recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor, and other agents expressed against E. coli). 9. Have received radiotherapy within 4 weeks prior to enrolment. 10. Have a history of drug addiction or drug abuse. 11. Other conditions that, in the judgement of the investigator, are not suitable for the use of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia (FN) across all chemotherapy cycles; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade >= 3 ANC (absolute neutrophil count) reduction in cycle 1 of chemotherapy;Incidence of grade >= 3 ANC (absolute neutrophil count) reduction in each chemotherapy cycle;Relative dose intensity (RDI) of chemotherapy in each cycle across all subjects;Number of chemotherapy delays across all treatment cycles;Safety endpoints: adverse events (AEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactZhaoqing Fan
Beiing Cancer Hospital
Outcome results
None listed