Doxorubicin Hydrochloride Liposome Injection Combination With Cyclophosphamide vs Pirarubicin Combination With Cyclophosphamide in Patients With Locally Advanced Breast Cancer
NCT ID: NCT02903524
Last Updated: 2016-09-16
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
PHASE4
300 participants
INTERVENTIONAL
2016-09-30
2018-12-31
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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control group
Pirarubicin combination with cyclophosphamide,4 cycles (each cycle is 21days) of chemotherapy
pirarubicin and cyclophosphamide
Experimental group
Doxorubicin Hydrochloride Liposome Injection combination with cyclophosphamide, 4 cycles (each cycle is 21 days) of chemotherapy
Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
Interventions
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Doxorubicin Hydrochloride Liposome injection and cyclophosphamide
pirarubicin and cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed breast cancer, stages IIb-IIIc.
* KPS performance status≥70.
* Measurable disease according to RECIST version 1.1.
* Normal cardiac function confirmed by baseline left ventricular ejection fraction (LVEF)≥50%.
* Adequate bone marrow reserve (WBC≥4.0×10(9)/L, neutrophils≥2.0×10(9)/L, platelets≥100×10(9)/L,and hemoglobin≥90g/L).
* Adequate hepatic and renal function.
* AST and ALT ≤ 2×institutional upper limit of normal；alkaline phosphatase ≤ 2×institutional upper limit of normal；bilirubin ≤ institutional upper limit of normal.
* Serum creatinine≥44 µmol/L and ≤133 µmol/L.
* Written informed consent are acquired.
* Not in pregnancy or the pregnancy tests of females is negative.
Exclusion Criteria
* Active and uncontrolled severe infection.
* Have accepted any other anti-tumor drug within 30 days before the first dose or
* received radiation treatment.
* Other situations that investigators consider as contra-indication for this study.
18 Years
70 Years
FEMALE
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Responsible Party
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Locations
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Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSPC-DMS-BC-03
Identifier Type: -
Identifier Source: org_study_id
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