Breast Cancer, Febrile Neutropenia, Neutropenia
Conditions
Keywords
breast cancer, neutropenia, febrile neutropenia
Brief summary
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.
Interventions
DRUGDrug: 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).
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).
DRUGrhG-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).
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and the duration of grade 3/4 neutropenia in cycle 1 | 21 days | Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate and the duration of grade 3/4 neutropenia in cycle 2-4 | Through cycle 2 to cycle 4 | Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L from cycle 2 to cycle 4. |
| Rate of the febrile neutropenia in cycle 1 | Through 4 cycles | Rate of ANC\<0.5×109/L and auxiliary temperature\>38.5℃. |
Countries
China
Outcome results
None listed