Based on favorable preclinical immunogenicity and antitumor profiles, the VRP-HER2 vector was advanced to a phase I clinical trial [10] for patients with metastatic or recurrent HER2 + malignancies (primarily breast cancer) defined as HER2 3+ by IHC or HER2 2+ by IHC with FISH amplification) who had progression of disease after prior HER2-targeted therapy (including trastuzumab, trastuzumab plus pertuzumab, T-DM1, or lapatinib). The gene discussed is ERBB2; the disease is breast carcinoma.