A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

Conditions
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Breast Cancer, Neutropenia, Febrile Neutropenia

Intervention / Treatment
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* Drug: Drug: Pegylated rhG-CSF: 100µg/kg
* Drug: Pegylated rhG-CSF: 6mg
* Drug: rhG-CSF 5ug/kg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Investigator diagnosis of breast cancer 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: Prior bone marrow or stem cell transplantation Received systemic antibiotics treatment within 72 h of chemotherapy Radiation therapy within 4 weeks of randomization into this study Pregnancy, lactation

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: Pegylated rhG-CSF: 100µg/kg<br>Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg | Drug: Drug: Pegylated rhG-CSF: 100µg/kg<br>* 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).<br>|
| Experimental: Pegylated rhG-CSF: 6mg<br>Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg | Drug: Pegylated rhG-CSF: 6mg<br>* 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).<br>|
| Active Comparator: rhG-CSF 5ug/kg/day<br>Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day | Drug: rhG-CSF 5ug/kg/day<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and the duration of grade 3/4 neutropenia in cycle 1 | Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and the duration of grade 3/4 neutropenia in cycle 2-4 | Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4. | Through cycle 2 to cycle 4 | 
| Rate of the febrile neutropenia in cycle 1 | Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃. | Through 4 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neutropenia, febrile neutropenia