metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mBC-Triple negative (TNBC) - 2nd Line (L2) breast cancer - triple negative breast cancer - triple negative metastatic mBC-Triple negative (TNBC) - 2nd Line (L2)
versus Standard of Care (SoC)
	sacituzumab govitecan
	ASCENT (all population), 2021 New England Journal of Medicine NCT02574455	RCT	mBC-Triple negative (TNBC) - 2nd Line (L2)	Sacituzumab govitecan	single agent chemotheraopy of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)	Patients with metastatic triple-negative breast cancer that was relapsed or refractory to two or more previous standard chemotherapy regimens for unresectable, locally andvanced or metastatic disease (previous thearapy had to include taxanes).	267 / 262	NA	suggested	suggested 49 % decrease in deaths (OS) (PE) suggested 57 % decrease in progression or deaths (PFS) (PE)
	ASCENT (patients without brain metastases), 2021 New England Journal of Medicine NCT02574455	RCT	mBC-Triple negative (TNBC) - 2nd Line (L2)	Sacituzumab govitecan	single agent chemotheraopy² of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)	Patients with metastatic triple-negative breast cancer that was relapsed or refractory to two or more previous standard chemotherapy regimens for unresectable, locally andvanced or metastatic disease (previous thearapy had to include taxanes).	235 / 233	NA	suggested	suggested 52 % decrease in deaths (OS) (PE) suggested 59 % decrease in progression or deaths (PFS) (PE)
	talazoparib
	EMBRACA, 2018 Annals of Oncology NCT01945775	RCT	mBC-Triple negative (TNBC) - 2nd Line (L2)	talazoparib	chemotherapy	Patients with HER2-negative locally advanced or metastatic breast cancer and a deleterious or suspected deleterious gBRCA1/2 mutation. Patients had received 3 or less previous cytotoxic regimens for advanced disease and previous treatment with a taxane, an anthracycline, or both (unless contraindicated).	287 / 144	NA	conclusif	inconclusive 15 % decrease in deaths (OS) (PE) demonstrated 46 % decrease in progression or deaths (PFS) (PE) demonstrated 4.0-fold increase in objective responses (ORR) (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)
	olaparib
	OlympiAD, 2017 N Engl J Med 2017 Aug 10;377(6):523-533. Ann Oncol 2019 Apr 1;30(4):558-566. NCT02000622	RCT	mBC - TNBC - L2 - all population	olaparib	standard chemotherapy	Patients with HER-2 negative metastatic breast cancer that was HR positive or triple negative. Patients had a confirmed deleterious or suspected deleterious germline BRCA mutation and had receive no more than 2 previous chemotherapy regimens for metastatic disease.	205 / 97	NA	conclusif	inconclusive 10 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in progression or deaths (PFS) (PE)
	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),deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS),progression or deaths (PFS) statistically significant 40 % decrease in DCR,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),deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS),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),deaths (OS) (PE)

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

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