Table 2.
Summary of Phase II clinical trials
| Author | Year | Number of patients | Study design | Study population | Objective response rate | Progression-free survival | Grade 3 adverse events |
|---|---|---|---|---|---|---|---|
| Burris et al40 | 2010 | 112 | Phase II single-arm | HER2-positive MBC who had tumor progression after prior HER2-directed therapy or received prior chemotherapy |
25.90% | 4.6 months | Hypokalemia (8.9%), thrombocytopenia (8.0%), and fatigue (4.5%) |
| Krop et al41 | 2012 | 110 | Phase II single-arm | HER2-positive MBC who had prior treatment with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine | 34.50% | 7.3 months | Thrombocytopenia (9.1%), fatigue (4.5%), and cellulitis (3.6%) |
| Hurvitz et al42 | 2013 | 137 | Phase II randomized to: | HER2-positive MBC or recurrent locally advanced breast cancer | |||
| T-DM1 versus trastuzumab plus docetaxel | First-line treatment | 64.20% | 14.2 months | 46.40% | |||
| First-line treatment | 58.00% | 9.2 months | 90.90% |
Abbreviations: HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; T-DM1, trastuzumab emtansine.