PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
NCT ID: NCT02805153
Last Updated: 2016-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
215 participants
INTERVENTIONAL
2013-04-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
rhG-CSF
Interventions
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PEG-rhG-CSF
rhG-CSF
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis of breast cancer patients
* chemotherapy naive
* Karnofsky Performance Status ≥ 70
* Written informed consent are acquired
Exclusion Criteria
* Have accepted radiotherapy within 4 weeks before anticipated the study
* pregnancy
* Other situations that investigators consider as contra-indication for this study
18 Years
70 Years
ALL
No
Sponsors
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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CSPC-PGC-IV-01
Identifier Type: -
Identifier Source: org_study_id
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