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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg |
|
| Pegylated rhG-CSF: 6mg | Experimental | Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg |
|
| rhG-CSF 5ug/kg/day | Active Comparator | Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Pegylated rhG-CSF: 100µg/kg | Drug | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Affiliated to Academy Military Medical Science | Beijing | Beijing Municipality | 100071 | China |
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| Pegylated rhG-CSF: 6mg | Drug | 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 | Drug | 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). |
|
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃.
| Through 4 cycles |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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