PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: PEG-rhG-CSF
Other Names:
|
Active Comparator: 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 |
Drug: rhG-CSF
Other Names:
|
Outcome Measures
Primary Outcome Measures
- the occurrence rate of grade IV neutropenia during the first chemotherapy cycle [through first cycle of chemotherapy,an average of 1 month]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with age between 18 and 70 years
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diagnosis of breast cancer patients
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chemotherapy naive
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Karnofsky Performance Status ≥ 70
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Written informed consent are acquired
Exclusion Criteria:
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uncontrolled infection
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Have accepted radiotherapy within 4 weeks before anticipated the study
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pregnancy
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Other situations that investigators consider as contra-indication for this study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC-PGC-IV-01