Chemotherapy-induced neutropenia
Conditions
Interventions
experimental arm:PEG-rhG-CSF injection (Hangzhou Jiuyuan Gene Engineering Co., Ltd.)
control arm:PEG-rhG-CSF injection (Neulastim, Amgen Inc.)
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 (including 18 and 70); 2. Breast cancer patients who were confirmed by histopathology, needed adjuvant or neoadjuvant chemotherapy and were suitable for TEC regimen (the first day of epirubicin 90mg / m2iv, the first day of cyclophosphamide 600mg / m2iv, the first day of docetaxel 75mg / m2iv, 21d as a cycle); 3. Patients with ECoG score of physical condition = 45kg; 5. The peripheral blood cell count met the chemotherapy conditions: WBC count >= 3.5 x 10^9 / L, ANC >= 1.5 x 10^9 / L, Hb >= 90g / L, PLT >= 100 x 10^9 / L, normal coagulation function, no bleeding tendency; 6. Patients with expected survival of more than 3 months; 7. The subjects are willing to use appropriate methods of contraception during the trial; 8. Patients who voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who received chemotherapy or radiotherapy within 4 weeks before admission (excluding local radiotherapy for bone metastasis); 2. Patients who have received hematopoietic stem cell transplantation or bone marrow transplantation; 3. Patients with a history of chronic myeloid leukemia or myelodysplastic syndrome; 4. Patients with current or previous sickle cell anemia; 5. Patients with other primary malignant tumors or other primary malignant tumors (excluding non-invasive non melanoma skin cancer, cervical carcinoma in situ, or other solid tumors that have not recurred for more than 10 years after effective treatment); 6. Diagnosis of patients with bone marrow metastasis; 7. Patients with brain metastasis were diagnosed; 8. Serious cardiovascular disease: there was a history of myocardial infarction or ischemic heart disease within 1 year before the first administration of the study drug; poorly controlled arrhythmia; history of congenital QT interval prolongation; obvious abnormality in ECG; abnormal left ventricular ejection fraction; NYHA heart function Grade III or IV; poor control of hypertension: after the use of antihypertensive drugs, the blood pressure is still systolic blood pressure > 150mmhg or diastolic blood pressure > 100mmhg; 9. Patients with primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine and blood system, which are serious, should not participate in this clinical trial; 10. Liver function index: alt, TBIL, AST >= 1.5 times of the upper limit value of normal in breast cancer patients without liver metastasis; alt, TBIL, AST >= 2.5 times of the upper limit value of normal in breast cancer patients with liver metastasis; renal function index: SCR >= 1.5 times of the upper limit value of normal; 11. Patients with known HIV positive serum; 12. Lactating and pregnant women and patients who plan pregnancy within 6 months after the last injection of the test drug in this study; 13. Patients with active infection (and body temperature >= 38 degrees C) or who have received systemic anti infection treatment within 72 hours before chemotherapy; 14. Patients who had received rhG CSF or PEG rhG CSF treatment within 4 weeks before admission; 15. Patients who have participated in three or more clinical trials of drugs in the past year, or have participated in any clinical trials of drugs in the past three months, as subjects, and have actually used the trial drugs; 16. Those who have allergic diseases or are allergic to docetaxel, epirubicin, cyclophosphamide, or protein drugs produced by rhG CSF and other E.coli systems; 17. Alcohol addicts or patients with a history of drug abuse; 18. Patients with serious mental or nervous system diseases, affecting the expression or observation of informed consent and / or adverse reactions; 19. Subjects considered by the researchers to have other unsuitable factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean duration of severe (grade 4) neutropenia during cycle 1 of chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depth of ANC nadir (lowest ANC) during cycle 1;Time to ANC recovery (days from ANC nadir until ANC increased to =2.0×109/l) during cycle 1;Incidence of grade 3/4 neutropenia in cycle 2, 3 and 4;Incidence of FN in cycle1, 2, 3 and 4;Proportion of antibiotics used in cycle1, 2, 3 and 4; | — |
Countries
China
Contacts
Public ContactYuankai Shi
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed