The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy
NCT ID: NCT02944604
Last Updated: 2019-01-18
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
240 participants
INTERVENTIONAL
2016-09-08
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PEG-rhG-CSF
Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF.
PEG-rhG-CSF
Interventions
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PEG-rhG-CSF
Eligibility Criteria
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Inclusion Criteria
2.Breast cancer diagnosed by pathology.
3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.
4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L, PLT（Platelet）≥80×10\^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.
5.KPS (Karnofsky performance status) score≥70.
6.Expected survival≥3 months.
7.Written informed consent are acquired.
Exclusion Criteria
2. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
3. Mental or nervous system disorders.
4. Severe heart, lung and central nervous system disorders.
5. Pregnant or lactating women.
6. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \> 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
7. Cr（creatinine） \>1.5×ULN.
18 Years
65 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Tao OUYANG
Chairman of Breast Center
Principal Investigators
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Tao Ouyang, MD
Role: STUDY_CHAIR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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CSPC-JYL-20160314
Identifier Type: -
Identifier Source: org_study_id
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