metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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 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
	KEYNOTE-119 (all population) DUPLICATE, 2019 Lancet Oncol 2021; 22:499-511-. NCT02555657	RCT	la/mBC - TNBC - L2 - all population	Pembrolizumab	Chemotherapy	Eligible participants were aged 18 years or older; had centrally confirmed metastatic triple-negative breast cancer; had received one or two previous systemic treatments for metastatic breast cancer, with documented disease progression on the most recent therapy; had receivedprevious treatment with an anthracycline or a taxane	312 / 310	low	inconclusive	inconclusive 3 % decrease in deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS) statistically significant 57 % 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 Standard of Care (SoC)
	pembrolizumab alone
	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)
	KEYNOTE-119 (PD-L1 CPS of 1 or more) DUPLICATE, 2019 Lancet Oncol 2021; 22:499-511-. NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	Chemotherapy		203 / 202	low	inconclusive	inconclusive 14 % decrease in deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS)
	KEYNOTE-119 (PD-L1 CPS of 10 or more), 2019 NCT02555657	RCT	la/mBC - TNBC - L2 - PDL1 positive	Pembrolizumab	Chemotherapy		96 / 98	low	inconclusive	inconclusive 22 % decrease in deaths (OS) (PE)
	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)