Phase II Study of Capecitabine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2–Overexpressing Metastatic Breast Cancer Pretreated With Anthracyclines or Taxanes

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Abstract
Purpose The oral fluoropyrimidine carbamate, capecitabine, is a highly active and well-tolerated treatment for metastatic breast cancer. In patients treated previously with anthracyclines and taxanes, capecitabine is an approved single-agent therapy. Trastuzumab, a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER-2), is also highly active in HER-2–overexpressing breast cancer. We have conducted a phase II study to confirm activity and feasibility of capecitabine and trastuzumab in combination in HER-2–overexpressing advanced/metastatic breast cancer. Patients and Methods Twenty-seven patients with HER-2–overexpressing metastatic breast cancer previously treated with anthracyclines and/or taxanes received oral capecitabine 1,250 mg/m2 bid for 14 days followed by a 7-day rest period combined with intravenous trastuzumab 4 mg/kg body weight on day 1 (loading dose) followed by 2 mg/kg weekly. Results Capecitabine/trastuzumab treatment achieved objective responses in 12 patients ...

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