Lapatinib as salvage therapy in metastatic breast cancer: Preliminary results from an expanded access program

12006 Background: Lapatinib, a TKI of human epidermal growth factor receptor type 2 (HER2) and epidermal growth factor receptor (EGFR), is active in combination with capecitabine in women with HER2-positive metastatic breast cancer progressing after trastuzumab-based therapy. The primary end point of this single arm, open label trial, was to offer the approval expanded access to lapatinib, in order to provide potential clinical benefit. Secondary objectives were progression free survival, overall survival and evaluation of serious adverse events. Methods: Women affected by locally advanced or metastatic breast cancer with ErbB2 overexpressing tumours, measurable disease and baseline left ventricular ejection fraction ≥ 50% that had progressed after regimens including anthracyclines, taxanes and trastuzumab were included. Since march 2007, 18 patients were enrolled. They received lapatinib at a dosage of 1,250 mg daily continuously plus capecitabine at a dosage of 2,000 mg/m2 on days 1 through 14 of a 21-d...