Overview
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Status:
Completed
Completed
Trial end date:
2020-01-31
2020-01-31
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Peking UniversityTreatments:
Lenograstim
Criteria
Inclusion Criteria:- Breast cancer patients in need for adjuvant chemotherapy confirmed by histopathology,
whom should accept ddEC regimen.
- ECOG<=1
- Expected survival is greater than 6 months
- Qualified for chemotherapy,WBC>=3*109/L, ANC>=1.5*109/L, Hb>=80g/L, PLT>=80*109/L.
With no bleeding tendency or systemic hematology disorder symptoms.
- No obvious EKG abnormality, no obvious cardiac dysfunction, and normal left
ventricular ejection fraction.
- Liver function, ALT and AST should less than 2.5 times of the upper limit.
- Renal function, Cr and BUN should less than 1.5 times of the upper limit.
- Subjects voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
- Total amount of doxorubicin used in previous chemotherapy>240mg/m2, or
epirubicin>360mg/m2
- Has received hematopoietic stem cell transplantation or bone marrow transplantation
- Other drugs are currently in clinical trials
- There are currently hard-to-control infections, body temperature is higher than 38
degrees.
- Received PEG-rhG-CSF treatment before enrollment
- Received chemotherapy in 4 weeks before enrollment
- Patients with any visceral metastasis
- Patients with severe heart, kidney, liver or any other important organs chronic
diseases
- Patients with severe uncontrolled diabetes
- Patients with allergic diseases, or allergies to this product or other biological
products derived from genetically engineered e. coli
- Suspected or real drug users, substance abusers, alcoholics
- Pregnant or lactating women
- Severe mental or neurological disorders that affect informed consent and adverse
reactions described or observed