A Phase 3 interventional study of Drug: Pegylated rhG-CSF: 100µg/kg and Pegylated rhG-CSF: 6mg in Breast Cancer, Neutropenia and Febrile Neutropenia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-08.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Prevention
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 330 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 571 studies on the registry; 86 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.
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Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
Drug: Drug: Pegylated rhG-CSF: 100µg/kg
Chemtherapy naive patients receiving chemotherapy and Pegylated rhG-CSF 6mg
Drug: Pegylated rhG-CSF: 6mg
Chemtherapy naive patients receiving chemotherapy and rhG-CSF 5ug/kg/day
Drug: rhG-CSF 5ug/kg/day
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).
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).
Drug page: Recombinant Granulocyte Colony-Stimulating Factor
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 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.
Time frame: 21 days
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.
Time frame: 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℃.
Time frame: Through 4 cycles
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Recombinant Granulocyte Colony-Stimulating Factor
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