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 carboplatin plus nab-paclitaxel
	atezolizumab plus carboplatin plus nab-paclitaxel
	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 or 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).
versus nab-paclitaxel, pegylated liposomal doxorubicin and cyclophosphamide
	atezolizumab plus nab-paclitaxel, pegylated liposomal doxorubicin and cyclophosphamide
	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 ,pCR (PE)
versus nab-paclitaxel
	durvalumab alone, nab-paclitaxel
	GeparNuevo, 2019 Ann. Oncol. 2019; : Ann Oncol 2022; 33:1149-1158-. NCT02685059	RCT	es-BC - TNBC - NA - all population	durvalumab followed by nab-paclitaxel	placebo followed by nab-paclitaxel	Patients with previously untreated uni- or bilateral primary, non-metastatic invasive TNBC with a tumour of at least 2 cm (cT2-cT4a-d) treated as neoadjuvant	88 / 86	some concern	suggested	suggested 76 % decrease in deaths (OS) (extension),deaths (OS) (extension) inconclusive 45 % increase in pCR ,pCR (PE)
versus carboplatin, paclitaxel
	atezolizumab plus carboplatin plus paclitaxel
	NCI 10013, 2022 NPJ Breast Cancer. 2022 NCT02883062	RCT	es-BC - TNBC - NA - all population	atezolizumab carboplatine plus paclitaxel	carboplatine plus paclitaxel	patients with clinical stages II and III TNBC.PDL1 status unknown for 59% control and 22% traitement arm patients	45 / 22	high	suggested	suggested 4.4-fold increase in pCR (PE)
versus paclitaxel followed by doxorubicin plus cyclophosphamide
	atezolizumab plus paclitaxel, pegylated liposomal doxorubicin and cyclophosphamide
	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,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.
versus placebo
	olaparib
	OlympiA (BIG 6-13, NSABP B-55) unpublished New England Journal of Medicine NCT02032823	RCT	es-BC - TNBC - NA - all population	olaparib	placebo	patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors	921 / 915	NA	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in iDFS (PE)
versus Standard of Care (SoC)
	pembrolizumab plus SoC
	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 untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer centrally confirmed	784 / 390	some concern	conclusif	demonstrated 34 % decrease in deaths (OS) (PE) demonstrated 37 % decrease in events or deaths (EFS) (PE) demonstrated 75 % increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (extended) (PE)

es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population