Table 1.

Ongoing phase III clinical trials with immunotherapy in patients with triple-negative breast cancer

ClinicalTrials.gov identifier	Number of patients	Management options	Class of treatment	Study arms	Primary outcome
NCT02954874	1000	Adjuvant	Immunotherapy	Arm I: no treatments Arm II: pembrolizumab	Invasive disease-free survival
NCT03498716	2300	Adjuvant	Immunotherapy + chemotherapy	Atezolizumab + adjuvant Antracycline/Taxane versus Chemotherapy alone	Invasive disease-free survival
NCT03197935	204	Neoadjuvant	Immunotherapy + chemotherapy	Atezolizumab and chemotherapy versus placebo and chemotherapy	Percentage of participants with pCR and percentage of participant with pCR in sub-population with PD-L1 positive
NCT03281954	1520	Neoadjuvant and adjuvant	Immunotherapy + chemotherapy	Neoadjuvant chemotherapy + atezolizumab versus placebo and adjuvant atezolizumab versus placebo	Pathologic complete response in the breast and lymph nodes and event-free survival
NCT03036488	1175	Neoadjuvant and adjuvant	Immunotherapy + chemotherapy	Pembrolizumab plus chemotherapy versus placebo + chemotherapy in neoadjuvant setting and pembrolizumab versus placebo in adjuvant setting	pCR and event-free survival
NCT03125902	540	Metastatic	Immunotherapy + chemotherapy	Atezolizumab and paclitaxel versus placebo and paclitaxel	Progression-free survival
NCT03371017	350	Metastatic	Immunotherapy + chemotherapy	Atezolizumab versus placebo	Overall survival

Abbreviations: pCR, pathologic complete response; PD-L1, programmed death-ligand 1.