Breast Cancer
Conditions
Keywords
PEG-rhG-CSF neutropenia
Brief summary
The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.
Interventions
DRUGPEG-rhG-CSF
Sponsors
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with age between 18 and 70 years * diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy * grade III/IV neutropenia after chemotherapy * KPS score≥70 * life expectancy of at least 3 months * Written informed consent are acquired
Exclusion criteria
* Have accepted any other drug related clinical trial within 4 weeks before anticipated * uncontrolled infection * pregnancy * Other situations that investigators consider as contra-indication for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy | up to 30 days after the patient study completion |
| the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy | up to 30 days after the patient study completion |
Secondary
| Measure | Time frame |
|---|---|
| the occurrence rate of III/ IV neutropenia during the whole chemotherapy process | through the study completion,an average of 5 months |
Outcome results
None listed