Table 2.

Efficacy analysis

	Toremifene 120 mg	Exemestane 25 mg	P value
Complete response	1	1
Partial response	4	0
Long stable disease (≥ 24 weeks)	14	11
Stable disease (< 24 weeks)	9	9
Progressive disease	12	24
* Withdrew prior to therapy	3*	0
** Drop out due to early adverse events (not evaluable)	3**	0
Intention-to-treat cohort	N = 46	N = 45
Clinical benefit rate% (95% CI)	41.3 (28.3-55.7)	26.7 (16.0-41.0)	0.14
Response rate% (95% CI)	10.8 (4.7-23.0)	2.2 (0.39-11.6)	0.083
Treatment-received cohort	N = 43	N = 45
Clinical benefit rate% (95% CI)	44.2 (30.4-58.9)	26.7 (13.0-40.1)	0.085
Response rate% (95% CI)	11.6 (5.1-24.5)	2.2 (1.2-16.7)	0.069

*Three patients of all 46 cases withdrew the protocol because of their preference or protocol violation prior to treatment. Except for these 3 cases, 43 cases were assessed as ‘Treatment-received cohort’. **Three other patients dropped out of toremifene 120 mg group due to early adverse events.

CI; confidence interval, ITT; intention-to-treat.