Table 4.

Phase II trials of Capecitabine alone or in combination therapy in patients with advanced or metastatic breast cancer.

Author, year of publication	Number of patients	Chemotherapeutics used	Doses of drugs	% overall response (CR+PR)	mTTP Months	Median Survival Months
First-line therapy for metastatic disease
Gradishar et al. [37], 2004	48	Capecitabine	- 1,650 mg/m2 per day (days 1-14)	51	10.6	29.9
		Paclitaxel	- 175 mg/m2 day 1
Ghosn et al. [38], 2003	30	Capecitabine	- 1,650 mg/m2 per day (days 1-14)	68	9.3	NR
		Vinorelbine	- 25 mg/m 2 days 1 and 8
O’Shaughnessy et al.	61	Capecitabine	- 2,510 mg/m2 per day (days 1-14)	30	4.1	19.6
[39], 2003	32	CMF	- CMF regimen	16	3.0	17.2
Single-agent therapy in metastatic disease pre-treated with anthracyclines
Talbot et al. [40], 2002	22	Capecitabine	- 2,510 mg/m2 per day (days 1-14)	36	3.0	7.6
	19	Paclitaxel	-175 mg/m2 day 1	26	3.1	9.4
Single-agent therapy in metastatic disease pre-treated with anthracyclines and taxanes
Blum et al. [41], 1999	162	Capecitabine	-2,510 mg/m2 per day (days 1-14)	20	3.1	12.8
Reichardt et al. [42], 2003	136	Capecitabine	-2,500 mg/m2 per day (days 1-14)	15	3.5	10.1
Fumoleau et al. [43], 2004	126	Capecitabine	-2,500 mg/m2 per day (days 1-14)	28	4.9	15.2
Blum et al. [44], 2001	75	Capecitabine	-2,510 mg/m2 per day (days 1-14)	29	3.2	12.2
Wist et al. [45], 2004	48	Capecitabine	-2,500 mg/m2 per day (days 1-14)	29	3.6	9.4
Combination therapy in metastatic disease pre-treated with anthracyclines
Batista et al. [46], 2004	73	Capecitabine	- 2,000 mg/m2 per day (days 1-14)	52	8.1	16.5
		Paclitaxel	- 175 mg/m2 day 1

Abbreviations: CR - complete response; PR - partial response; mTTP - median time to progression; NR - not reached. All capecitabine doses were divided equally and dosed twice daily. Regimens were administered every 3 weeks. CMF: cyclophosphamide 600 mg/m², methotrexate 40 mg/m², and fluorouracil 600 mg/m² IV every 3 weeks.