. 2014 Jul 23;6:103–113. doi: 10.2147/BCTT.S67297

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%
			T-DM1 versus trastuzumab plus docetaxel	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.