Trial Information

A Phase III Randomized Study of Primary Chemotherapy With Adriamycin/Cyclophosphamide(AC) vs Taxotere/Xeloda(TX) for Stage II and III Breast Cancer

- Patients will be randomized to receive regimen A (AC) and regimen B(TX),
preoperatively,as follows: Regimen A (AC): Intravenous infusion of Adriamycin 60mg/m2 , over
30 min, onD1 and Intravenous infusion of cyclophosphamide 600 mg/m2 over 30 min on D1.
Regimen B(TX): Intravenous infusion of Taxotere 75 mg/m2 over 1 hr, on D1, and Xeloda
1000mg/m2.p.o. BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times.
Premedication for regimen A includes antiemetics, for regimen B, dexamethasone as routinely
given.

Patients who do not respond to the initial two cycles of preoperative chemotherapy will
undergo operation.

The response rate will be determined by the number of patients with complete and partial
responses according to RECIST guidelines. Pathologic complete response is defined as no
pathologic evidence of residual disease. Safety will be evaluated by the frequency,
severity, and relationship of adverse events graded by NCI Common Toxicity Criteria(CTC)
that occur during the treatment and follow-up periods. Time to disease progression will be
calculated from the date of study entry to the first objective documentation of progressive
disease. Response duration will be measured from the date a patient first fulfills the CR or
PR criteria to the first date of objective documentation of disease progression. Survival
time will be calculated from the date of study entry to the date of death