Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
- Registration Number
- NCT00919880
- Lead Sponsor
- Tao OUYANG
- Brief Summary
The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 148
Inclusion Criteria
- female patients between 18 and 65 years old
- 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
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Exclusion Criteria
- pregnant or lactating females
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental carboplatin+ paclitaxel - Experimental paclitaxel - Active Comparator paclitaxel -
- Primary Outcome Measures
Name Time Method significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2) within the first 14 days (plus or minus 3 days) after surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing Cancer Hospital Breast Center
🇨🇳Beijing, Beijing, China