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)
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 carboplatin, gemcitabine
	atezolizumab based treatment, carboplatin, gemcitabine
	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 carboplatin
	atezolizumab based treatment, carboplatin
	TBCRC, 2024 NCT03206203	RCT	la/mBC - TNBC - L2 - all population	carboplatin atezolizumab, 1200 mg	carboplatin	clinical stage IV or metastatic invasive TN breast cancer. 0 to 1 prior treatments for metastatic disease, and no prior carboplatin in the metastatic setting or prior immune-oncology treatment were eligible. Patients were not stratified by PD-L1 status.	56 / 50	high	inconclusive	suggested 54 % decrease in deaths (OS),deaths (OS) inconclusive 34 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
versus pegylated liposomal doxorubicin and cyclophosphamide
	atezolizumab based treatment, pegylated liposomal doxorubicin and cyclophosphamide
	Alice, 2022 J Transl Med 2020; 18:252-. Nat Med 2022; 28:2573-2583-. NCT03164993	RCT	la/mBC - TNBC - L2 - all population	atezolizumab and pegylated liposomal doxorubicin (PLD) and low-dose cyclophosphamide	placebo and pegylated liposomal doxorubicin (PLD) and low-dose cyclophosphamide	patients with mTNBC, 18 years of age or older, with no more than one prior line of chemotherapy in the metastatic setting. Inclusion of patients both with and without PD-L1 expression in tumors was allowed in this trial	42 / 28	high	suggested	suggested 43 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE) The addition of atezolizumab to PLD/cyclophosphamide was tolerable with an indication of clinical benefit
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	la/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 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),deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS),progression or deaths (PFS) statistically significant 40 % decrease in DCR,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),deaths (OS) (PE) statistically significant 60 % increase in progression or deaths (PFS),progression or deaths (PFS) statistically significant 57 % decrease in DCR,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 carboplatin, gemcitabine
	atezolizumab based treatment, carboplatin, gemcitabine
	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),deaths (OS),deaths (OS) (PE)
versus Standard of Care (SoC)
	pembrolizumab alone
	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),deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS),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),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),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),deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS),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),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),deaths (OS) (PE) statistically significant 35 % increase in progression or deaths (PFS),progression or deaths (PFS)

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

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