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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 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 | Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF(HHPG-19K) 100µg/kg in cycle 2 to 4 |
|
| Pegylated rhG-CSF 150μg/kg | Experimental | Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF(HHPG-19K)150 μg/kg in cycle 2 to 4 |
|
| G-CSF 5 μg/kg/d | Active Comparator | Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated rhG-CSF 100μg/kg | Drug | Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L | Proportion and the duration of subjects developing ANC lower than 1.0×109/L | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the febrile neutropenia in cycle 1 and cycle 2 | Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃ | 6 weeks |
| ANC alteration in cycle 1 and cycle 2 | Weekly laboratory ANC value alteration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZeFei Jiang, M.D | 307 Hospital Affiliated to Academy Military Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital Affiliated to Academy Military Medical Science | Beijing | China |
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|
| Pegylated rhG-CSF:150 μg/kg | Drug | Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy). |
|
|
| rhG-CSF 5 μg/kg/day | Drug | Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L(3)ANC counts exceed 15×109/L at anytime. |
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| 6 weeks |
| 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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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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