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

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Treatments: 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