Table 1.
Trial | Study design | No. of patients | HER2 status | Regimen duration of treatment | Response rate | Prognosis |
LOGiC | Phase III/1st Randomized Double Blind | 545 | HER2 amplification | Lapatinib + XELOX XELOX No description of duration | non-significant prolongation | |
TyTAN | Phase III/2nd Parallel group Randomized | 1923 | HER2 amplification | Lapatinib +Paclitaxel Paclitaxel 24 mo | 27% vs 9% | OS: 11.0 mo vs 8.9 mo PFS: 5.4 mo vs 4.4 mo |
HERBIS-1 | Phase II/1st Non-Randomized | 56 | IHC 3+ IHC 2+ FISH + | S-1/cisplatin + trastuzumab No description of duration | 68% | OS: 16.0 mo PFS: 7.8 mo |
PF299804 | Phase II/2nd Non-Randomized | 28 (estimated) | IHC 3+ IHC 2+ FISH + | PF299804 Cycles of 28 d | 7.40% | Ongoing |
HIROISE (NCT01450646) | Phase III/1st Randomized | 400 (estimated) | Trastuzumab + cisplatin + capecitabine 33 wk | Ongoing | ||
NCT01472029 | Phase II/1st Non-Randomized | 53 | 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab No description of duration | Ongoing | ||
NCT01130337 | Phase II/preoperative Non-Randomized | 36 | Trastuzumab + XELOX 12 mo | Ongoing | ||
NCT01522768 | Phase II/advanced Non-Randomized | 40 | IHC 3+ IHC 2+ FISH + | Afatinib + trastuzumab 24 mo | Ongoing | |
NCT01402401 | Phase II/2nd Non-Randomized | 21 | IHC 3+ IHC 2+ FISH + | AUY922 + trastuzumab Every 6 wk | Ongoing | |
NCT01641939 | Phase II/III/1st Randomized | 412 (estimated) | IHC 3+ IHC 2+ FISH + | Trastuzumab emtansine Taxane 12 wk | Ongoing |
HER2: Human epidermal growth factor receptor; OS: Overall survival; PFS: Progression-free survival; IHC: Immunohistochemistry; FISH: Fluorescence in situ hybridization.