Table 1.

Second- and Third-Line Metastatic Breast Cancer Drug Approvals

Year of Approval	Type of Approval	Drugs	No. of Patients	Drug Doses	End Points	HR	95% CI	Log-Rank P
1994	RA	P	471	P: 175 mg/m2 v 135 mg/m2	TTP: median, 4.2 v 3.0 months	0.75		.027
1996	AA	D	309	D: 100 mg/m2	ORR: 37.9%		31.0 to 44.8
1998	RA	D	392	D: 100 mg/m2 v M: 12 mg/m2 + V: 6 mg/m2	OS: median 11.4 v 8.7 months	0.73	0.58 to 0.93	.01
1998	RA	T	222	T: 4 mg/kg load, 2 mg/kg weekly	ORR: PR, 12%; CR, 2%		7.73 to 16.3
1998	AA	C	162	C: 2,500 mg/m2	ORR: 25.6%		13.5 to 41.2
2001	RA	C/D	511	C: 2,500 mg/m2 + D: 75 mg/m2 v D: 100 mg/m2	OS: median, 442 v 352 days	0.77	0.63 to 0.95	.01
2005	RA	A-bound P	460	A: 260 mg/m2	ORR: 21.5%		16.2 to 26.7	.003
				P: 175 mg/m2	ORR: 11.1%		6.9 to 15.1
2007	RA	L/C	399	L: 1,250 mg + C: 2,000 mg/m2 v C: 2,500 mg/m2	TTP: median IND, 27.1 v 18.6 weeks	0.57	0.43 to 0.77	< .001
					TTP: median INV, 23.9 v 18.3 days	0.72	0.56 to 0.92	.008
					OS: median, 75 v 65.8 weeks	0.89	0.71 to 1.10	.276
2007	RA	I	126	40 mg/m2	ORR: 12.4% DR: median, 6 months		6.9 to 9.9
2007	RA	I/C	752	I: 40 mg/m2 + C: 2,000 mg/m2 v C: 2,500 mg/m2	PFS: median, 5.7 v 4.1 months	0.69	0.58 to 0.83	< .001
					OS: median, 12.9 v 11.1 months*	0.90	0.77 to 1.05	.19
2010	RA	E	762	E: 1.4 mg/m2 v PC	OS: median, 13.1 v 10.6 months	0.81	0.66 to 0.99	.041

Abbreviations: A, albumin; AA, accelerated approval; C, capecitabine; D, docetaxel; DR, duration of response; E, eribulin; HR, hazard ratio; I, ixabepilone; IND, independent assessment; INV, investigator assessment; L, lapatinib; M, mitomycin; ORR, objective response rate; OS, overall survival; P, paclitaxel; PC, physician's choice; PFS, progression-free survival; RA, regular approval; RR, response rate; T, trastuzumab; TTP, time to progression; V, vinblastine.

^*Updated OS.