Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

Study Overview
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Brief Summary
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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, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg. In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.

Detailed Description
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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 administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly. Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or >60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.

Official Title
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A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer

Conditions
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Neutropenia

Intervention / Treatment
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* Drug: Pegfilgrastim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pegfilgrastim 3mg<br>Pegfilgrastim 3mg per chemotherapy cycle | Drug: Pegfilgrastim<br>* Pegfilgrastim 3mg per chemotherapy cycle<br>|
| Active Comparator: pegfilgrastim 6mg<br>Pegfilgrastim 6mg per chemotherapy cycle | Drug: Pegfilgrastim<br>* Pegfilgrastim 3mg per chemotherapy cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| timely recovery of ANC | The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10^9/L before the second chemotherapy cycle. Blood routine test was used. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| febrile neutropenia in cycle1 | the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken. | 1 month | 
| grade 3/4 neutropenia in cycle 1 | the incidence of absolute neutrophil count (ANC) <1.0×10^9/L before the second chemotherapy cycle. Blood routine test was used. | 1 month | 
| grade 4 neutropenia in cycle 1 | the incidence of absolute neutrophil count (ANC) <0.5×10^9/L before the second chemotherapy cycle. Blood routine test was used. | 1 month | 
| hospitalization due to neutropenia | the incidence of unplanned hospitalization due to neutropenia | 1 month |