Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer

Launched by PEKING UNIVERSITY · Jul 3, 2019

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility 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