The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
Overview
- Phase
- Phase 4
- Intervention
- PEG-rhG-CSF
- Conditions
- Breast Cancer
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Enrollment
- 215
- Primary Endpoint
- the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with age between 18 and 70 years
- •diagnosis of breast cancer patients
- •chemotherapy naive
- •Karnofsky Performance Status ≥ 70
- •Written informed consent are acquired
Exclusion Criteria
- •uncontrolled infection
- •Have accepted radiotherapy within 4 weeks before anticipated the study
- •pregnancy
- •Other situations that investigators consider as contra-indication for this study
Arms & Interventions
Experimental/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.
Intervention: PEG-rhG-CSF
Active Comparator/rhG-CSF
patients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10\^9/L was documented after the expected nadir, or for a maximum of 14 days
Intervention: rhG-CSF
Outcomes
Primary Outcomes
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
Time Frame: through first cycle of chemotherapy,an average of 1 month
Secondary Outcomes
- the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)(through the next three consecutive cycles chemotherapy,an average of 3 months)
- the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)(through the next three consecutive cycles chemotherapy,an average of 3 months)