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Summary Background: To explore the activity of lapatinib with a novel trial design focused on the drug target rather than on histology. Methods: Patients with HER2 amplified gastro-esophageal, bladder, ovarian, or uterine tumors were enrolled into a double-blinded randomized discontinuation study of lapatinib 1,500 mg PO daily. The planned sample size was 250 patients with HER2 amplified tumors,...
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