metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)
versus non active control
	avelumab alone
	A-Brave, 2024 Journal of Clinical Oncology NCT02926196	RCT	es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)	avelumab	control	Patiennts at High-risk Triple Negative Breast Cancer after completion of standard treatment with curative intent including surgery and neoadjuvant/adjuvant chemotherapy.	-/-	NA	suggested	suggested 34 % decrease in deaths (OS) inconclusive 18 % decrease in RFS/DFS (PE) inconclusive 19 % decrease in RFS/DFS (PE) One year adjuvant avelumab versus control does not significantly improve DFS in high-risk TNBC patients. Nevertheless, the secondary enpoind OS was significanlty improved with avelumab vs control.
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
	NeoTRIPaPDLA unpublished Ann Oncol 2022; 33:534-543-. NCT02620280	RCT	es-BC - TNBC - NA - all population	atezolizumab plus carboplatine plus nab-paclitaxel	carboplatine plus nab-paclitaxel	Neoadjuvant Therapy in TRIPle Negative Breast Cancer (early or locally advanced)	88 / 86	NA	inconclusive	no statistically significant result
versus paclitaxel followed by doxorubicin plus cyclophosphamide
	atezolizumab based treatment
	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) statistically significant 81 % increase in SAE (any grade) 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
	durvalumab alone
	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) inconclusive 45 % increase in pCR (PE)
	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-. NCT03036488	RCT	es-BC - TNBC - NA - all population	pembrolizumab	placebo	previously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase;	784 / 390	low	conclusif	demonstrated 12.6-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE)
versus placebo plus SoC
	atezolizumab plus nab-paclitxel followed by doxorubicin plus 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 (PE)
es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive
versus placebo plus SoC
	atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide
	IMpassion-031 (PDL1>1%), 2020 Lancet 2020 Oct 10;396(10257):1090-1100. NCT03197935	RCT	es-BC - TNBC - NA - PDL1 positive	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 with PDL1 >1%	78 / 76	low	suggested	suggested 1.2-fold increase in pCR (PE)

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

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

es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive