PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy

Official Title
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The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: PEG-rhG-CSF
* Drug: rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age between 18 and 70 years diagnosis of breast cancer patients chemotherapy naive Karnofsky Performance Status ≥ 70 Written informed consent are acquired Exclusion Criteria: uncontrolled infection Have accepted radiotherapy within 4 weeks before anticipated the study pregnancy Other situations that investigators consider as contra-indication for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental/PEG-rhG-CSF<br>patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy. | Drug: PEG-rhG-CSF<br> <br> * Other names: pegfilgrastim;|
| Active Comparator: Active Comparator/rhG-CSF<br>patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10^9/L was documented after the expected nadir, or for a maximum of 14 days | Drug: rhG-CSF<br> <br> * Other names: filgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence rate of grade IV neutropenia during the first chemotherapy cycle |  | through first cycle of chemotherapy,an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle) |  | through the next three consecutive cycles chemotherapy,an average of 3 months | 
| the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle) |  | through the next three consecutive cycles chemotherapy,an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-rhG-CSF