A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
NCT ID: NCT01611051
Last Updated: 2013-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
330 participants
INTERVENTIONAL
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pegylated rhG-CSF: 100µg/kg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
Drug: Pegylated rhG-CSF: 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Pegylated rhG-CSF: 6mg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg
Pegylated rhG-CSF: 6mg
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
rhG-CSF 5ug/kg/day
Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day
rhG-CSF 5ug/kg/day
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Interventions
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Drug: Pegylated rhG-CSF: 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Pegylated rhG-CSF: 6mg
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
rhG-CSF 5ug/kg/day
Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 70 years
* ECOG performance status ≤ 1
* Chemotherapy naïve
* Body weight ≥ 45kg
* Hemoglobin ≥ 90g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L
* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN
Exclusion Criteria
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Radiation therapy within 4 weeks of randomization into this study
* Pregnancy, lactation
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hospital Affiliated to Academy Military Medical Science
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HHPG-19K -III-01
Identifier Type: -
Identifier Source: org_study_id
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