A phase I study of combination therapy with capecitabine and paclitaxel for patients with inoperable breast cancer or recurrent breast cancer

: A dose-escalation study was conducted for patients with inoperable or recurrent breast cancer in order to determine the recommended dose (RD) of capecitabine combined with a fixed dose of weekly paclitaxel. Capecitabine was administered twice daily from day 1 through day 14 combined with paclitaxel given on days 1 and 8, every 21 days. Dose-limiting toxicities(DLT)were evaluated during the first two cycles. Three patients were recruited at one of two dose levels (capecitabine 1,255 mg/m2 or 1,657 mg/m2, paclitaxel 80 mg/m2). In this study, no DLT was seen in each level, and the RD of capecitabine was determined to be 1,657 mg/m2.