Status:
COMPLETED
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Neutropenia
Eligibility:
FEMALE
18-69 years
Phase:
PHASE3
Brief Summary
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently. According to the package inserts in America, Europe...
Detailed Description
All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m\^2 (or pirarubicin 60mg/m\^2) and cyclophosphamide 600mg/m\^2 were a...
Eligibility Criteria
Inclusion
- female aged 18-69 years
- diagnosed pathologically as early breast cancer
- with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
- received no prior chemotherapy (chemotherapy naïve)
- have Karnofsky performance status ≥ 80,
- baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10\^9/L,ANC≥2.0X10\^9/L, platelet count ≥100X10\^9
- adequate cardiac, hepatic and renal function
Exclusion
- enrolled onto or had not yet completed other investigational drug trials
- allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
- pregnant or lactating women;
- previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05283616
Start Date
May 15 2017
End Date
October 15 2021
Last Update
March 19 2024
Active Locations (1)
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1
Department of Medical Oncology
Beijing, Beijing Municipality, China, 100021