. 2014 Mar 24;7:491–500. doi: 10.2147/OTT.S34235

Table 1.

Completed Phase II and Phase III trial results for T-DM1

Study/phase	Number of patients	Arms	Endpoints	HR; 95% CI
EMILIA Trial⁴⁵ Phase III	991^*	T-DM1 vs lapatinib and capecitabine	MOS: 30.9 vs 25.1 months	HR 0.68; 95% CI 0.55–0.85 P<0.001
Burris et al⁴² Phase II	112	Single-arm study; patients pretreated with chemotherapy	ORR: 25.9% PFS: 4.6 months	95% CI 18.4%–34.4% 95% CI 3.9–8.6 months
Krop et al⁴³ Phase II	110	Single-arm study; patients pretreated with anthracycline, trastuzumab, taxane, capecitabine, and lapatinib therapy	ORR: 32.7% PFS: 7.3 months	95% CI 24.1–42.1%
Hurvitz et al⁴⁴ Phase II randomized	137^**	T-DM1 vs trastuzumab plus docetaxel	ORR: 64% vs 58% PFS: 14.2 vs 9.2 months	HR 0.594, P=0.035

Notes:

Patients with HER2-positive locally advanced or metastatic breast cancer after prior trastuzumab and taxane-based chemotherapy;

^**

first-line treatment in HER2-positive metastatic breast cancer patients.

Abbreviations: CI, confidence interval; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; MOS, median overall survival; ORR, objective response rate; PFS, progression-free survival; T-DM1, trastuzumab emtansine; vs, versus.