metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
breast cancer - triple negative breast cancer - triple negative
versus Standard of Care (SoC)
	durvalumab alone
	Saphir02 Breast-Immuno, 2021 Nat Med 2021; 27:250-255-. NCT02299999	RCT	breast cancer - triple negative	durvalumab	chemotherapy	patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after initial chemotherapy (maintenance chemotherapy).	131 / 68	some concern	inconclusive	inconclusive 40 % increase in progression or deaths (PFS) (PE) Maintenance chemotherapy was more effective than durvalumab in patients with hormone receptor-positive and Her2-negative disease.
la/mBC - TNBC - L1 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - all population
versus placebo plus nab-paclitaxel
	atezolizumab plus nab-paclitaxel
	IMpassion-130 (all population), 2018 Lancet Oncol. 2020; 21:44-59 N. Engl. J. Med. 2018; 379:2108-2121 Jpn. J. Clin. Oncol. 2019; 49:1083-1091 Ann. Oncol. 2020; : Ann Oncol 2021 Aug;32(8):983-993. NCT02425891	RCT	la/mBC - TNBC - L1 - all population	atezolizumab plus nab-paclitaxel	placebo plus nab-paclitaxel	patients with untreated metastatic triple-negative breast cancer (TNBC) treated with nab-paclitaxel	451 / 451	low	conclusif	inconclusive 14 % decrease in deaths (OS) (PE) demonstrated 20 % decrease in progression or deaths (PFS) (PE) suggested 20 % decrease in PFS (extension)
versus placebo plus paclitaxel
	atezolizumab plus paclitaxel
	IMpassion-131 (all population), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	la/mBC - TNBC - L1 - all population	Atezolizumab plus paclitaxel	placebo plus paclitaxel	Patients had metastatic or unresectable locally advanced measurable TNBC, had received no prior chemotherapy or targeted therapy for aTNBC and had completed any prior (neo)adjuvant chemotherapy for early breast cancer 12 months before being randomised to the trial.	431 / 220	NA	inconclusive	inconclusive 14 % decrease in progression or deaths (PFS) (PE) Atezolizumab (Tecentriq) in combination with paclitaxel did not demonstrate a statistically significant improvement in progression-free survival (PFS) as a first-line treatment for patients with PD-L1–positive triple-negative breast cancer (TNBC) / qualitative results only NO ROB
versus placebo plus SoC
	pembrolizumab plus SoC
	KEYNOTE-355 (all population), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. N Engl J Med 2022 Jul 21;387(3):217-226. J Natl Cancer Inst 2024; 116:717-727-. NCT02819518	RCT	la/mBC - TNBC - L1 - all population	Pembrolizumab plus chemotherapy	placebo plus chemotherapy	patients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (all population)	566 / 281	low	inconclusive	inconclusive 11 % decrease in deaths (OS) (PE) suggested 18 % decrease in progression or deaths (PFS) (PE) statistically significant 76 % decrease in objective responses (ORR) OS results from ESMO Congres 2021
la/mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - PDL1 positive
versus placebo plus nab-paclitaxel
	atezolizumab plus nab-paclitaxel
	IMpassion-130 (PDL1>1%), 2018 Lancet Oncol. 2020; 21:44-59 N. Engl. J. Med. 2018; 379:2108-2121 Jpn. J. Clin. Oncol. 2019; 49:1083-1091 Ann. Oncol. 2020; : Ann Oncol 2021 Aug;32(8):983-993. NCT02425891	RCT	la/mBC - TNBC - L1 - PDL1 positive	atezolizumab plus nab-paclitaxel	placebo plus nab-paclitaxel	patients with untreated metastatic triple-negative breast cancer treated with nab-paclitaxel, and PDL1 positive population (>1%)	185 / 184	low	conclusif	suggested 29 % decrease in deaths (OS) (PE) demonstrated 38 % decrease in progression or deaths (PFS) (PE) suggested 37 % decrease in PFS (extension)
versus placebo plus SoC
	pembrolizumab plus SoC
	KEYNOTE-355 (CPS>1), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. NCT02819518	RCT	la/mBC - TNBC - L1 - PDL1 positive	Pembrolizumab plus chemotherapy	placebo plus chemotherapy	patients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>1)	425 / 211	low	suggested	inconclusive 14 % decrease in deaths (OS) (PE) suggested 25 % decrease in progression or deaths (PFS) (PE) OS results from ESMO Congres 2021
	KEYNOTE-355 (CPS>10), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. ESMO Congres 2021 NCT02819518	RCT	la/mBC - TNBC - L1 - PDL1 positive	Pembrolizumab plus chemotherapy	placebo plus chemotherapy	patients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>10)	220 / 103	low	conclusif	demonstrated 27 % decrease in deaths (OS) (PE) demonstrated 34 % decrease in progression or deaths (PFS) (PE) OS results from ESMO Congres 2021
versus Standard of Care (SoC)
	atezolizumab plus paclitaxel
	IMpassion-131 (PD-L1 > 1%), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	la/mBC - TNBC - L1 - PDL1 positive	Atezolizumab plus paclitaxel	placebo plus paclitaxel	Patients had metastatic or unresectable locally advanced measurable TNBC, had received no prior chemotherapy or targeted therapy for aTNBC and had completed any prior (neo)adjuvant chemotherapy for early breast cancer 12 months before being randomised to the trial.	191 / 101	NA	inconclusive	inconclusive 18 % decrease in progression or deaths (PFS) (PE)
la/mBC - TNBC - L2 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - all population
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-132, ITT population, 2024 Future Oncol 2019; 15:1951-1961 Ann Oncol 2024; 35:630-642-. NCT03371017	RCT	la/mBC - TNBC - L2 - all population	atezolizumab plus SOC	placebo plus SOC	Patients with locally advanced/metastatic TNBC recurring ≤12 months after completing standard (neo)adjuvant anthracycline and taxane chemotherapy or surgery in early stage	297 / 298	low	inconclusive	no statistically significant result OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-119 (all population), 2019 Lancet Oncol 2021; 22:499-511-. NCT02555657	RCT	la/mBC - TNBC - L2 - all population	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC)	312 / 310	some concern	inconclusive	inconclusive 3 % decrease in deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS) statistically significant 40 % decrease in DCR
la/mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - PDL1 positive
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-132, PD-L1 positive population, 2024 Future Oncol 2019; 15:1951-1961 Ann Oncol 2024; 35:630-642-. NCT03371017	RCT	la/mBC - TNBC - L2 - PDL1 positive	atezolizumab plus SOC	placebo plus SOC	Patients with locally advanced/metastatic TNBC recurring ≤12 months after completing standard (neo)adjuvant anthracycline and taxane chemotherapy or surgery in early stage	177 / 177	low	inconclusive	inconclusive 7 % decrease in deaths (OS) (PE)
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-119 PD-L1 positive (CPS = 10 or more), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC)	96 / 98	some concern	inconclusive	inconclusive 22 % decrease in deaths (OS) (PE)
	KEYNOTE-119 PD-L1 positive (CPS = 1 or more), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC)	203 / 202	some concern	inconclusive	inconclusive 14 % decrease in deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS)
	KEYNOTE-119 (PDL1 CPS>10), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 10 only	96 / 98	some concern	inconclusive	inconclusive 22 % decrease in deaths (OS) (PE)
	KEYNOTE-119 (PDL1 CPS>1), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	chemotherapy (single agent)	patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 1 only	203 / 202	some concern	inconclusive	inconclusive 14 % decrease in deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS)
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) 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.
	A-Brave Stratum A, 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	inconclusive	inconclusive 19 % decrease in RFS/DFS (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
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).
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)

breast cancer - triple negative breast cancer - triple negative

la/mBC - TNBC - L1 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - all population

la/mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - PDL1 positive

la/mBC - TNBC - L2 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - all population

la/mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) la/mBC - TNBC - L2 - PDL1 positive

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