Phase II study of sequential administration of vinorelbine -capecitabine combination followed by weekly docetaxel as first line chemotherapy for advanced breast cancer

2004 
817 Background: The combination of vinorelbine (N) and capecitabine (C) has demonstrated to be active and safe regimen for advanced breast cancer (ABC) (Ghosn; ASCO 03); capecitabine and docetaxel (D) combination in anthracycline failure has demonstrated an interesting outcomes, but with high toxicity profile. In order to improve patient clinical benefit by minimizing toxicity, we conducted a phase II trial with these 3 agents in sequential schedule. Methods: Eligible patients (pts) had ABC (locally advanced or metastatic), measurable disease, no prior chemotherapy for ABC, WHO PS<2, adequate bone morrow, renal and hepatic functions and written informed consent. Pts received 4 cycles of N: 25 mg/m2 on day 1 & day 8 in combination with C: 825 mg/m2 twice a day from day 1 to day 14 every 3 weeks. Pts with objective response or stable disease received twelve consecutive weeks of D: 25 mg/m2. Results: Between July 02 and Sept 03, forty-two consecutive pts were enrolled into the study; median age: 58 years (36...
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