Breast Cancer
Conditions
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.
Interventions
DRUGcarboplatin+ 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
DRUGpaclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Sponsors
Tao OUYANG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed