Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Rate and the duration of grade 3/4 neutropenia in cycle 1
Outcome Description:
Proportion and the duration of subjects developing ANC lower than 1.0 × 109/L.
Outcome Time Frame:
21 days
Safety Issue:
No
Authority:
China: Food and Drug Administration
Study ID:
HHPG-19K -III-01
NCT ID:
NCT01611051
Start Date:
March 2012
Completion Date:
Related Keywords:
- Breast Cancer
- Neutropenia
- Febrile Neutropenia
- breast cancer
- neutropenia
- febrile neutropenia
- Breast Neoplasms
- Fever
- Neutropenia