Table 1. Patients demography and characteristics.

	Gemcitabine and Vinorelbine		Gemcitabine and Cisplatin		Gemcitabine and Capecitabine
Randomised patients (n)	46		45		50
Median age (years) (range)	58	(38–77)	60	(36–74)	60	(34–78)
Median KPS (%) (range)	100	(70–100)	95	(70–100)	95	(70–100)
	N	%	N	%	N	%
Tumour metastatic sites
Visceral	41	89.1	37	82.2	45	90.0
Non-visceral only	5	10.9	8	17.8	5	10.0
Number of metastatic sites
1	12	26.1	13	28.9	12	24.0
2	19	41.3	24	53.3	24	48.0
⩾3	14	30.4	8	17.8	13	26.0
Unknown	1	2.2			1	2.0
Hormone receptor status
Positive	28	60.9	26	57.8	25	50.0
Negative	16	34.8	18	40.0	18	36.0
Unknown	2	4.4	1	2.2	7	14.0
HER2 status
Positive (IHC3+, FISH+)	4	8.7	7	15.6	5	10.0
Negative	32	69.6	30	66.7	35	70.0
Unknown	10	21.7	8	17.8	10	20.0
Menopausal status
Premenopausal	10	21.7	8	17.8	4	8.0
Postmenopausal	19a	41.3	23	51.1	34a	68.0
Unknown	17	37.0	14	31.1	12	24.0
Prior hormonal treatment
Prior hormonal treatment	26	56.5	27	60.0	28	56.0
Unknown	2	4.45	—	—	1	2.0
Prior chemotherapy (CTX)
Prior anthracyclines	24	52.2	26	57.8	31	62.0
Prior anthracyclines+taxanes	20	43.5	19	42.2	19	38.0
Prior taxanes	1	2.2	—	—	—	—
Unknown	1	2.2	—	—	—	—
Prior (neo)adjuvant CTX	33	71.7	32	71.1	39	78.0
Line of CTX for MBC
1st line	18	39.1	15	33.3	18	36.0
2nd line	15	32.6	13	28.9	17	34.0
⩾3rd line	11	23.9	8	17.8	10	20.0
Unknown	2b	4.4	9b	20.0	5	10.0

Abbreviations: FISH=fluorescence in situ hybridisation; HER2=human epidermal growth factor receptor 2; IHC3+=immunohistochemistry (DAKO 3+); KPS=Karnofsky performance scale; MBC=metastatic breast cancer.

^aStatistical significant (P=0.01).

^bStatistical significant (P=0.03).