- Patients with HER2/neu-overexpressing tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) should have received trastuzumab (Herceptin®) and/or lapatinib (Tykerb®) in the adjuvant or metastatic setting (unless contraindicated) and have progressed while on treatment of metastatic disease or within 12 months of completion of adjuvant therapy.