study evaluating peg-g-csf injectionin preventing neutropenia after chemotherapy

Conditions: Neutropenia, Chemotherapy-Induced Febrile; Breast Neoplasm Female

Summary: to evaluate the efficacy, safety, and immunogenicity of peg-g-csf injection (kexing biopharmaceutical co., ltd.) for the prevention of neutropenia after chemotherapy, using the peg-g-csf injection ( neulasta®, amgen europe b.v.) as a positive control.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, ≤75 years 2. female breast cancer patients with a pathohistologically confirmed diagnosis requiring first-time adjuvant or neoadjuvant chemotherapy and for whom the following regimens are appropriate: ① ec regimen (epirubicin 90 mg/m2 iv day 1, cyclophosphamide 600 mg/m2 iv day 1) ② tc regimen (cyclophosphamide 600 mg/m2 iv day 1, docetaxel 75 mg/m2 iv day 1) ③ tcb regimen ( docetaxel 75 mg/m2 iv day 1, carboplatin auc=5 iv day 1); note: tcb regimens such as the combination of anti-her2 targeting drugs h (trastuzumab) and p (pertuzumab) can also be included. 3. physical condition ecog score ≤ 1; 4. weight ≥ 45kg; 5. peripheral blood cell counts eligible for chemotherapy: white blood cell (wbc) count ≥ 3.5 x 109/l, neutrophil count (anc) ≥ 1.5 x 109/l, hemoglobin (hb) ≥ 90 g/l, platelet (plt) count ≥ 100 x 109/l, normal coagulation or abnormalities of no clinical significance, and no tendency to bleed; 6. survival is expected to be 6 months or more; 7. the subject is willing to use an appropriate method of contraception for the duration of the trial; 8. subjects agreed to follow the trial treatment protocol and visit schedule, enrolled voluntarily, and signed a written informed consent form. exclusion criteria: 1. the subjects who have received radiation therapy within 4 weeks prior to randomization; 2. those who have received hematopoietic stem cell transplantation or bone marrow transplantation 3. patients who have been treated with g-csf analogs or peg-g-csf analogs within 4 weeks prior to randomization; 4. subjects with a history of chronic granulocytic leukemia or myelodysplastic syndromes; 5. people at high risk for ards; 6. patients with unexplained splenomegaly on physical examination and/or ct scan or ultrasound, as well as any condition that may cause splenomegaly (e.g., thalassemia, glandular fever, malaria, etc.); 7. patients who currently have or have had sickle cell anemia; 8. those with a combined history of malignant tumors (except for the following: cured non-melanoma skin cancer, cervical cancer in situ, limited prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years); 9. those diagnosed with advanced breast cancer combined with distant metastases; 10. patients with known cerebrovascular malformations (e.g., cerebral hemangiomas), epilepsy; 11. patients with severe mental or neurological disorders; 12. patients with severe cardiovascular disease: history of myocardial infarction within 1 year prior to first administration of study drug; sick sinus syndrome, atrioventricular block ii or greater, ventricular fibrillation, torsional ventricular tachycardia, sustained ventricular tachycardia; electrocardiogram indicative of abnormal clinically significant qrs wave lowering; congenital prolonged history of the qt interval; left ventricular ejection fraction \ 160 mmhg systolic and/or \>100 mmhg diastolic despite antihypertensive medications; congestive heart failure; stable coronary artery disease; unstable angina pectoris; 13. liver function indexes: alt, ast, tbil ≥1.5 times the upper limit of normal before enrollment; kidney function indexes: scr ≥1.5 times the upper limit of normal; 14. positive for hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) and peripheral blood hepatitis b virus (hbv) dna test is greater than the normal range; positive for hepatitis c virus (hcv); positive for human immunodeficiency virus (hiv); 15. those with a current active infection (and a temperature ≥38°c) or who have received systemic anti-infective therapy within 72 hours prior to chemotherapy; 16. patients with severe mouth ulcers; 17. participated in 3 or more clinical trials of a drug within the last year, or participated in any clinical trial of a drug within the last 3 months, as a subject and actually used the test drug; 18. hypersensitivity to the adjuvant or neoadjuvant chemotherapeutic agents used (e.g., docetaxel, epirubicin, carboplatin, cyclophosphamide) and to peg-g-csf and g-csf analogs; 19. lithium-treated patients were required during the clinical trial; 20. alcohol-dependent individuals or those with a history of substance abuse; 21. lactating and pregnant females and those planning a pregnancy within 6 months of the last injection of the test drug in this study; 22. combined primary diseases of the cerebrovascular, hepatic, renal, endocrine, and hematologic systems of a severity judged by the investigator to be inappropriate for participation in this clinical trial; 23. other patients who, in the judgment of the investigator, are not suitable subjects for this trial.