. 2019 Oct 10;13(2):425. doi: 10.4081/oncol.2019.425

Table 1.

Study characteristics.

Year; Author	Study characteristics			Subject characteristics				Intervention			NOS Score
	Study design	Phase	Aims/ Purpose	Median age (years)	Sample size	Disease stage	Target molecule	Intervention Treatment groups	Line of therapy	Follow-up (months)
2018; Adams S⁶⁸	Single-arm trial, multi-cohort, multicenter	Ib	To examine the safety, tolerability, and preliminary clinical activity of atezolizumab + nab-paclitaxel in mTNBC	55	33	IV	PD-L1	Atezolizumab + nab-paclitaxel	≥1L	24.4 (22.1-28.8)	8
2018; Adams S Cohort A⁷⁰	Single-arm trial, open-label	II	To examine the efficacy and safety of pembrolizumab monotherapy in large cohort of patients with previously treated mTNBC regardless of PD-L1 expression	53.5	170	IV	PD-1	Pembrolizumab	≥1L	9.6 (0.1-25.7)	7
2018; Adams S Cohort B⁷¹	Single-arm trial, open-label	II	To examine the safety and efficacy of single-agent pembrolizumab in patients with previously untreated PD-L1+ mTNBC	52.5 (26-91)	84	IV	PD-1	Pembrolizumab	1L	12.3 (0.9-23.5)	7
2018; Schmid P⁷²	Randomized, multi-cohort	III	To investigate the efficacy and safety of first line atezolizumab + nab-paclitxel, as compared with placebo + nabnab- paclitaxel, in patients with locally advanced or mTNBC	Atezolizumab– nab-paclitaxel: 55 Placebo–nab- paclitaxel: 56	902	III/IV	PD-L1	Atezolizumab + nab-paclitaxel vs placebo vs nab-paclitaxel	1L	Atezolizumab–nab- paclitaxel: 13.0 Placebo–nab- paclitaxel: 12.5	9
2018; Emens LA⁶⁹	Single-arm trial, multi-cohort, open-label	I	To evaluate the safety, clinical activity, and biomarkers associated with the use of single agent atezolizumab in patients with mTNBC	53	116	IV	PD-L1	Atezolizumab	≥1L	25.3 (0.4-45.6)	6
2017; Dirix LY⁷³	Single-arm trial, open-label, international	I	To assess the activity of avelumab, a PD-L1 inhibitor, in patients with mBC	52.5 (31-80)	58	III/IV	PD-L1	Avelumab	≥1L	10.0 (6.0-15.2)	7
2016; Nanda R⁷⁴	Non-randomized, multicenter	Ib	To assess the safety and antitumor activity of PD-1 inhibitor pembrolizumab in patients with advanced TNBC	50.5	32	IV	PD-1	Pembrolizumab	≥1L	10.0 (0.4-19.5)	7

NOS, Newcastle-Ottawa Scale; mTNBC, metastatic triple-negative breast cancer; mBC, metastatic breast cancer; TNBC, triple-negative breast cancer; PD-1, programmed