Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
NCT ID: NCT00919880
Last Updated: 2014-08-15
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
PHASE2
148 participants
INTERVENTIONAL
2009-07-31
2010-12-31
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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Experimental
carboplatin+ paclitaxel
carboplatin AUC 2mg/mL\*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Active Comparator
paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Interventions
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carboplatin+ paclitaxel
carboplatin AUC 2mg/mL\*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007
* able and willing to give consent to participate in the study
Exclusion Criteria
* previous treatment for breast cancer
* other tumor history
* instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
* allergy history to similar drugs
* concurrent disease or condition that would make the patient inappropriate for study participation
* resist to participate in the study
18 Years
65 Years
FEMALE
No
Sponsors
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Tao OUYANG
OTHER
Responsible Party
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Tao OUYANG
Chairman of Breast Center
Principal Investigators
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Tianfeng Wang, Doctor
Role: STUDY_CHAIR
Beijing Cancer Hospital Breast Center
Locations
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Beijing Cancer Hospital Breast Center
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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B04
Identifier Type: -
Identifier Source: org_study_id
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