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 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
DRUGPegylated rhG-CSF 100μg/kg
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).
DRUGPegylated rhG-CSF:150 μg/kg
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).
DRUGrhG-CSF 5 μg/kg/day
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.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathology diagnosis of breast cancer,Chemotherapy naïve * ECOG performance status 0-1 * Age 18 to 70 years * Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy * White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L * Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN * No obvious cardiac dysfunction
Exclusion criteria
* Prior bone marrow or stem cell transplantation * Received systemic antibiotics treatment within 72 h of chemotherapy * Other disease might have influence on bone marrow function * Radiation therapy within 4 weeks of randomization into this study * Previous exposure or or allergic to Pegylated rhG-CSF * Pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L | 6 weeks | Proportion and the duration of subjects developing ANC lower than 1.0×109/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the febrile neutropenia in cycle 1 and cycle 2 | 6 weeks | Rate of ANC\<0.5×109/L and auxiliary temperature\>38.5℃ |
| ANC alteration in cycle 1 and cycle 2 | 6 weeks | Weekly laboratory ANC value alteration |
Countries
China
Outcome results
None listed