metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population
versus placebo
	pembrolizumab alone
	KEYNOTE-522, 2020 N. Engl. J. Med. 2020; 382:810-821 N Engl J Med 2022; 386:556-567-. JAMA Netw Open 2023; 6:e2342107-. Ann Oncol 2024; 35:429-436-. J Natl Cancer Inst 2024; 116:1654-1663-. The New England Journal of Medicine N Engl J Med 2024; 391:1981-1991-. NCT03036488	RCT	es-BC - TNBC - NA - all population	pembrolizumab plus SOC	placebo plus SOC	previously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer centrally confirmed	784 / 390	low	conclusif	demonstrated 37 % decrease in events or deaths (EFS) (extended) (PE) demonstrated 12.6-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE)
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-031 (all population), 2020 Lancet 2020 Oct 10;396(10257):1090-1100. Jpn J Clin Oncol 2022; 52:1124-1133-. NCT03197935	RCT	es-BC - TNBC - NA - all population	Atezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	placebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	neoadjuvant setting in participants with early stage (stage II-III) triple negative breast cancer	165 / 168	low	conclusif	demonstrated 95 % increase in pCR (PE)
versus Standard of Care (SoC)
	atezolizumab plus SoC
	ALEXANDRA/IMpassion-030, 2024 Journal of Clinical Oncology European Journal of Cancer Annals of Oncology NCT03498716	RCT	es-BC - TNBC - NA - all population	atezolizumab plus chemotherapy	chemotherapy	Patients with newly diagnosed Stage II-III (es) primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery,	1101 / 1098	NA	inconclusive	inconclusive 11 % increase in iDFS (PE) At the final analysis, the addition of atezo to adjuvant anthracycline- and taxane-based chemo did not improve iDFS in the ITT population of stage II-III TNBC or in any of the subgroups interrogated. Safety data remain consistent with the known profile of atezo in early TNBC.
	NeoTrip Michel Angelo, 2022 Annals of Oncology Ann Oncol 2022; 33:534-543-. NCT02620280	RCT	es-BC - TNBC - NA - all population	atezolizumab plus SOC	SOC	patients with previously untreated histologically confirmed unilateral triple negative breast cancer, early high risk versus locally advanced. Pts with metastatic disease (stage IV) were excluded.	138 / 142	some concern	inconclusive	no statistically significant result The addition of atezolizumab to nab-paclitaxel and carboplatin did not significantly increase the rate of pCR in women with TNBC. In multivariate analysis, the presence of PD-L1 expression was the most significant factor influencing the rate of pCR (OR 2.08).