Table 1.

Baseline Patient Demographics and Disease Characteristics

Characteristic	Ixabepilone Plus Capecitabine (n = 609)		Capecitabine (n = 612)
	No.	%	No.	%
Age, years
Median	53		53
Range	23-78		24-81
Measurable disease stratum	480		480
Karnofsky performance status, %
70-80	195	32	156	25
90-100	406	67	453	74
< 70	2	0.3	2	0.3
Not reported	6	1	1	0.2
Hormone receptor status
ER positive	341	56	330	54
ER negative	226	37	250	41
HER2 positive	85	14	100	16
HER2 negative	396	65	396	65
ER-negative, PR-negative, HER2-negative	122	20	134	22
Site of visceral disease
Liver	273	45	276	45
Lung	221	36	217	35
Extent of disease (No. of disease sites)
≥ 2	422	70	427	70
< 2	184	30	185	30
Prior regimens in the metastatic setting
≥ 3	2	0.3	3	0.5
2	112	18	107	17
1	371	61	388	63
0	124	20	114	19
Prior chemotherapy and hormonal therapy
Anthracycline
Resistant*	164	27	149	24
Received minimum cumulative dose	337	55	352	57
Taxanes
Resistance*	299	49	286	48
Progressive disease as best response to prior taxane (metastatic setting)	101	17	105	17
Trastuzumab	48	8	48	8
Hormonal therapy	384	63	382	62

NOTE. Percentages may not add up to 100% due to rounding and/or unknown data for some patients.

Abbreviations: ER, estrogen receptor; PR, progesterone receptor; HER2, human epidermal growth factor receptor 2.

^*Resistance = progression during treatment with or within 3 months of last dose (metastatic) or recurrence within 6 months of last dose (neoadjuvant/adjuvant).