metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1)
versus nab-paclitaxel, placebo
	toripalimab
	TORCHLIGHT, 2024 Nat Med 2024; 30:249-256-. NCT04085276	RCT	mBC - Triple negative (TNBC) - 1st Line (L1)	toripalimab and nab-paclitaxel	placebo and nab-P	Patients aged at least 18 years with histologically confirmed TNBC, previously untreated or no more than one previous systemic chemotherapy regimen for stage IV or locally advanced TNBC that is not amenable to surgery	353 / 178	low	inconclusive	suggested 31 % decrease in deaths (OS) suggested 23 % decrease in progression or deaths (PFS) (PE) statistically significant 73 % increase in SAE (grade 3-4)
mBC - TNBC - L1 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population
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	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
versus Standard of Care (SoC)
	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	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)
	atezolizumab plus paclitaxel
	IMpassion-131 (all population), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	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
mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-132, 2024 Future Oncol 2019; 15:1951-1961 Ann Oncol 2024; 35:630-642-. NCT03371017	RCT	mBC - TNBC - L1 - 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	297 / 298	low	inconclusive	inconclusive 7 % decrease in deaths (OS) (PE) OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
	pembrolizumab plus SoC
	KEYNOTE-355 (CPS>1), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. NCT02819518	RCT	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	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 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	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)
	atezolizumab plus paclitaxel
	IMpassion-131 (PD-L1 > 1%), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	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)
mBC - TNBC - L2 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - all population
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-119 (all population), 2019 Annals of Oncology, Elsevier Lancet Oncol 2021 Apr;22(4):499-511. Eur J Cancer 2023; 195:113393-. NCT02555657	RCT	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
mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - PDL1 positive
versus Standard of Care (SoC)
	pembrolizumab alone
	KEYNOTE-119 (PDL1 CPS>1), 2019 Annals of Oncology, Elsevier Lancet Oncol 2021 Apr;22(4):499-511. NCT02555657	RCT	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)
	KEYNOTE-119 (PDL1 CPS>10), 2019 Annals of Oncology, Elsevier Lancet Oncol 2021 Apr;22(4):499-511. NCT02555657	RCT	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)

mBC - Triple negative (TNBC) - 1st Line (L1) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1)

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

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

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

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