Table 1.

Select clinical trials of nab-P in metastatic breast cancer

Trial	Phase	Patient population	Regimen	Efficacy		Selecta Grade ≥ 3 AEs, %
				PFS, mo	OS, mo	Neutropenia	Neuropathy
Monotherapy
Ibrahim et al. 2005 [11]	2	First line (n = 15)	nab-P 300 mg/m2 q3w	TTP 6.1	14.6	51	11b
		Second line or later (n = 48)
Gradishar et al. 2009 [12] & 2012 [13]	2	First line	nab-P 300 mg/m2 q3w (n = 76)	11.0	27.7	43	21b
			nab-P 100 mg/m2 qw 3/4 (n = 76)	12.8	22.2	25	9b
			nab-P 150 mg/m2 qw 3/4 (n = 74)	12.9	33.8	45	22b
Gradishar et al. 2005 [10]	3	First line(n = 97)	nab-P 260 mg/m2 q3w	TTP 5.3	15.0	30	10b
		Second line or later (n = 132)
Combination therapy with cytotoxic agents
Roy et al. 2009 [14]	2	First line (N = 50)	nab-P 125 mg/m2 + gemcitabine 1000 mg/m2 qw 2/3	7.9	Median not reached; 6-mo OS 92 %	54	8b
Schwartzberg et al. 2012 [15]	2	First line (N = 50)	nab-P 125 mg/m2 qw 2/3 + oral capecitabine 825 mg/m2 twice daily on days 1 and 15 of a 21-day cycle	10.6	19.9	10	2b
		HER2 negative
Combination therapy with targeted agents
Seidman et al. 2013 [16]	2	First line, HER2 negative	nab-P 130 mg/m2 qw + bev 10 mg/kg q2w (n = 79)	8.8	23.7	33	46
			nab-P 260 mg/m2 q2w + bev 10 mg/kg q2w (n = 54)	5.8	19.0	6	56
			nab-P 260 mg/m2 q3w + bev 15 mg/kg q3w (n = 75)	7.7	21.3	16	33
Rugo et al. 2015 [17]	3	First line, predominantly HER2 negative	nab-P 150 mg/m2 qw 3/4 + bev 10 mg/kg q2w (n = 271)	9.3	23.5	51	27
Mirtsching et al. 2011 [18]	2	First line (N = 72)	nab-P 125 mg/m2 qw 3/4 + trastuzumab 4 mg/kg bolus then 2 mg/kg qw (HER2 positive only)	14.5	29.0	11b	8b
		HER2 positive (n = 22)
Yardley et al. 2013 [19]	2	First/second line (N = 60)	nab-P 125 mg/m2 qw 3/4 + oral lapatinib 1250 mg daily	9.1	Median not reached	22b	3b

AE adverse event, bev bevacizumab, HER2 human epidermal growth factor receptor, nab-P nab-paclitaxel, OS overall survival, PFS progression-free survival, TTP time to tumor progression, qw every week, q2w every 2 weeks, q3w every 3 weeks, qw 2/3 weekly for the first 2 of 3 weeks; qw 3/4 weekly for the first 3 of 4 weeks

^aNeutropenia and neuropathy are common grade ≥ 3 toxicities associated with nab-P treatment

^bNo grade 4 events