PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia
- Registration Number
- NCT02805205
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 484
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF PEG-rhG-CSF patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method the occurrence rate of III/ IV neutropenia during the whole chemotherapy process through the study completion,an average of 5 months