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