An extended regimen for treatment of HER-2/neu overexpressed/amplified canceris described, with involves de-liveringa course of neratinib therapy to HER-2/neu overexpressed/amplified cancerpatients following the completion of surgicaland adjuvant therapy. The neratinib regimen may be continued for upwards oftwelve months to five years. Also provided arepharmaceutical kits designed to facilitate compliance with the regimen.