Status:
COMPLETED
Efficacy and Safety of 4.5mg PEG-rhG-CSF Per Cycle in Preventing Neutropenia After Intensive Chemotherapy for Breast Cancer
Lead Sponsor:
Peking University
Conditions:
Breast Cancer
Neutropenia
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief 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, acce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04009941
Start Date
August 1 2019
End Date
January 31 2020
Last Update
October 28 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142