A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
NCT ID: NCT01907529
Last Updated: 2019-08-09
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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UNKNOWN
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2019-08-31
2021-12-31
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
TREATMENT
NONE
Study Groups
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Chemo plus Endostar
Docetaxel, epirubicin and cyclophosphamide plus endostar
docetaxel, epirubicin and cyclophosphamide plus endostar
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles
Chemo only
docetaxel, epirubicin and cyclophosphamide
docetaxel, epirubicin and cyclophosphamide
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
Interventions
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docetaxel, epirubicin and cyclophosphamide
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
docetaxel, epirubicin and cyclophosphamide plus endostar
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles
Eligibility Criteria
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Inclusion Criteria
* Age 18-70
* No evidence of distant metastasis
* No previous therapy
* Normal hematologic function
* No abnormality of renal or liver function
* Written informed consent
Exclusion Criteria
* Any concurrent uncontrolled medical or psychiatric disorder
* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
* Being pregnant or nursing
18 Years
70 Years
FEMALE
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Responsible Party
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Yunjiang Liu
M.D, Chief Physician of Breast Cancer Dept, Vice-President of Hebei Medical University Fourth Hospital
Principal Investigators
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YUNJIANG LIU, M.D.& PhD.
Role: PRINCIPAL_INVESTIGATOR
Hebei Medical University Fourth Hospital
Locations
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Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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HBMUFH-101
Identifier Type: -
Identifier Source: org_study_id
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