Table 2.

Efficacy results (ITT population)

Characteristic	Lapatinib + vinorelbine ( N =44)
Investigator assessed Overall Response Rate (ORR)
Overall response rate (CR+PR), n (%)	18 (41)
(95% CI)	(26.4, 55.4)
Best response, n (%)
Complete response (CR)	4 (9)
Partial response (PR)	14 (32)
Stable disease (SD)	14 (32)
Progressive disease (PD)	5 (11)
Unknown	7 (16)
Investigator assessed Progression-Free Survival (PFS)
Patients, n (%)
Progressed or died due to any cause *	29 (66)
Censored, follow-up ended	15 (34)
Kaplan-Meier estimate for PFS (weeks)
Median (95% CI)	24.1 (16.9, 36.7)
Time to response (TTR)
Patients, n (%)	18 (100)
Kaplan-Meier estimate for TTR (weeks)
Median (95% CI)	7.5 (7.1, 8.1)
Duration of Response (DoR)
Patients, n (%)	18 (100)
Progressed or died due to any cause	13 (72)
Censored, follow-up ended	5 (28)
Kaplan-Meier estimate for DoR (weeks)
Median (95% CI)	32.0 (18.0, 42.3)

*All deaths were due to breast cancer, therefore progression-free survival and time to progression (TTP) were the same.

CI, confidence interval.