Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer

INTERVENTION: Arm A: Patients do not utilize genetic diagnosis for sensitivity to paclitaxel and receive primary chemotherapy with paclitaxel (Patients are randomized to arm A or B with ratio 1 to 4.) Arm B: Patients utilize genetic diagnosis for sensitivity to paclitaxel. Patients who are diagnosed as sensitive to paclitaxel receive primary chemotherapy with paclitaxel. Pateints who are diagnosed as insensitive to paclitaxel receive primary chemotherapy with FEC100.(Patients are randomized to arm A or B with ratio 1 to 4.) CONDITION: Breast cancer PRIMARY OUTCOME: Accuracy of prediction system of sensitivity: Elucidate a population of patients who are sensitive to paclitaxel by performing quantitative RT‐PCR on about 50 genes before administration of paclitaxel. Evaluate pathological response by paclitaxel in patients who are diagnosed as positive sensitivity and compare those in patients who do not receive sensitivity testing. Improvement of pathological response rate is judged as high accuracy of prediction system for sensitivity SECONDARY OUTCOME: Examine the influence of genetic diagnosis on pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant‐metastasis free survival, disease free survival and overall survival.; Examine the association between genetic polymorphism and adverse events by chemotherapy INCLUSION CRITERIA: Histologically confirmed breast cancer with tumor size 3cm and more in stageIIA‐StageIIIB. Operable case. Age below 70. PS 0 or 1. Life expectancy 6 months and more. WBC:4,000/micro L and more or ANC:2,000/micro L and more. Platelet:100,000/micro L and more. Hemoglobin:9g/dl and more. AST(GOT),ALT(GPT):twice of an upper limit of normal value and less. Serum total bilirubin:1.5 mg/dl and less. BUN,Creatinine:an upper limit of normal value and less. ECG within normal limit. Given written consent.