NCT00919880
Completed
Phase 2
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
Tao OUYANG1 site in 1 country148 target enrollmentJuly 2009
ConditionsBreast Cancer
Overview
- Phase
- Phase 2
- Intervention
- carboplatin+ paclitaxel
- Conditions
- Breast Cancer
- Sponsor
- Tao OUYANG
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Tao OUYANG
Chairman of Breast Center
Peking University
Eligibility Criteria
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
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
Arms & Interventions
Experimental
Intervention: carboplatin+ paclitaxel
Experimental
Intervention: paclitaxel
Active Comparator
Intervention: paclitaxel
Outcomes
Primary Outcomes
significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
Time Frame: within the first 14 days (plus or minus 3 days) after surgery
Study Sites (1)
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