Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer

Table 3 Efficacy

	Phase 1b	Phase 2a
	Total (N = 60)	Group A (n = 22)	Group B (n = 22)	All (N = 44)
Best overall response,^a n (%)
Complete response	1 (2)	1 (4.8)^b	1 (4.5)	2 (4.7)^c
Partial response	34 (57)	13 (61.9)^b	15 (68.2)	28 (65.1)^c
Stable disease	22 (37)	6 (28.6)^b	5 (22.7)	11 (25.6)^c
Progressive disease	3 (5)	1 (4.8)^b	1 (4.5)	2 (4.7)^c
Clinical benefit rate^d
n (%)	40 (66.7)	12 (54.5)	13 (59.1)	25 (56.8)
95 % CI	53.5 − 78.3	32.7 − 74.0	38.3 − 79.3	41.6 − 71.0
No. of patients with measurable disease	n = 55	n = 21	n = 21	n = 42
Objective response rate^e
n (%)	30 (54.5)	10 (47.6)	11 (52.4)	21 (50.0)
95 % CI	40.6 − 68.0	27.6 − 70.2	29.8 − 72.4	34.6 − 65.4

CI confidence interval
^aAt any time point with responses ordered complete response > partial response > stable disease > progressive disease
^bOf 21 patients with best response
^cOf 43 patients with best response
^dIncludes patients with complete response, partial response, or stable disease of ≥6 months duration, as assessed by the investigator
^eIncludes only those patients with confirmed complete and partial responses, and is calculated based on patients with measurable disease

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