- Recurrent or progressive metastatic disease after at least 1-2 courses of standard HER2-targeted therapies with known clinical benefit i.e. trastuzumab (Herceptin(TM)), pertuzumab (Perjeta(TM)), lapatinib (Tykerb(TM)), ado-trastuzumab emtansine (TDM1) (Kadcyla(TM)) or other investigational HER2-directed therapies (e.g. MGAH22).