metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mBC - Triple negative (TNBC) - (neo)adjuvant (NA) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - (neo)adjuvant (NA)
versus carboplatin, pegylated liposomal doxorubicin and cyclophosphamide
	atezolizumab based treatment, carboplatin, pegylated liposomal doxorubicin and cyclophosphamide
	NSABP B-59/GBG 96-GeparDouze, 2018 Journal of Clinical Oncology NCT03281954	RCT	mBC - Triple negative (TNBC) - (neo)adjuvant (NA)	atezolizumab plus NAC (neoadjuvant chemotherapy)	placebo plus NAC	Patients with centrally-confirmed ER-neg, PR-neg, HER2-neg invasive breast cancer by ASCO/CAP guidelines, stage T2 or T3 if cN0 or cN1 with negative biopsy or T1c, T2, or T3 if cN1 with positive biopsy or cN2 or cN3. LVEF > 55% and no significant cardiac history	773 / 777	NA	inconclusive	inconclusive 20 % decrease in events or deaths (EFS),events or deaths (EFS),events or deaths (EFS) (PE)
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
	camrelizumab alone, nab-paclitaxel
	FUTURE-SUPER_immunomodulatory subtype, 2024 Lancet Oncol 2024; 25:184-197-. NCT04395989	RCT	mBC - Triple negative (TNBC) - 1st Line (L1)	camrelizumab plus famitinib plus nab-paclitaxel	nab-paclitaxel	females aged 18–70 years with an histologically confirmed, untreated metastatic or recurrent triple-negative breast cancer	69 / 70	some concern	inconclusive	suggested 54 % decrease in progression or deaths (PFS),progression or deaths (PFS) the subtyping-based precision treatment showed significantly improved progression-free survival compared with standard chemotherapy in the first-line treatment of metastatic triple-negative breast cancer.
versus Standard of Care (SoC)
	capivasertib plus paclitaxel
	PAKT (PIK3CA/AKT1/PTEN-altered), 2020 J Clin Oncol 2020; 38:423-433-. NCT02423603	RCT	mBC - Triple negative (TNBC) - 1st Line (L1)	capiversatib plus paclitaxel	placebo plus paclitaxel	Patients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.	17 / 11	NA	suggested	suggested 70 % decrease in progression or deaths (PFS)
la/mBC - TNBC - L1 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - all population
versus nab-paclitaxel
	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	la/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)
versus nab-paclitaxel plus placebo
	nab-paclitaxel plus toripalimab
	TORCHLIGHT, 2024 Nat Med 2024; 30:249-256-. NCT0377759	RCT	la/mBC - TNBC - L1 - all population	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)
versus paclitaxel
	atezolizumab plus paclitaxel
	IMpassion-131 (all population), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	la/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	low	inconclusive	inconclusive 14 % decrease in progression or deaths (PFS),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
versus Standard of Care (SoC)
	capivasertib plus paclitaxel
	PAKT (all population), 2020 J Clin Oncol 2020; 38:423-433-. NCT02423603	RCT	la/mBC - TNBC - L1 - all population	capiversatib plus paclitaxel	placebo plus paclitaxel	Patients had histologically confirmed, metastatic or locally advanced TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted, but previous adjuvant or neoadjuvant chemotherapy was allowed.	70 / 70	NA	suggested	suggested 39 % decrease in deaths (OS) inconclusive 26 % decrease in progression or deaths (PFS) (PE)
	ipatasertib plus paclitaxel
	LOTUS, 2017 Lancet Oncol 2017; 18:1360-1372-. Breast Cancer Res Treat 2021; 189:377-386-. NCT02162719	RCT	la/mBC - TNBC - L1 - all population	ipatasertib plus paclitaxel	placebo plus paclitaxel	Women with locally advanced or metastatic TNBC not amenable to curative resection. Previous systemic therapy for locally advanced or metastatic disease was not permitted. Previous (neo)adjuvant treatment completed at least 6 months before the first dose was allowed	62 / 62	NA	suggested	suggested 40 % decrease in progression or deaths (PFS) (PE)
	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	la/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
	veliparib plus paclitaxel plus carboplatin
	BrighTNess (velaparib-P-C (arm A) vs paclitaxel - carboplatin (arm B)), 2018 Lancet Oncol 2018; 19:497-509-. NCT02032277	RCT	la/mBC - TNBC - L1 - all population	veliparib plus paclitaxel plus carboplatin	placebo plus paclitaxel plus carboplatin	Patients: women who had histologically or cytologically confirmed invasive TNBC, clinical stage II-III	316 / 160	NA	inconclusive	inconclusive 12 % increase in events or deaths (EFS) (PE) inconclusive 25 % increase in events or deaths (EFS) (PE) inconclusive 16 % decrease in pCR (PE)
	BrighTNess (velaparib-P-C (arm A) vs paclitaxel alone (arm C)), 2018 Lancet Oncol 2018; 19:497-509-. NCT02032277	RCT	la/mBC - TNBC - L1 - all population	veliparib plus paclitaxel plus carboplatin	placebo matching veliparib plus placebo matching carboplatin plus paclitaxel	Patients: women who had histologically or cytologically confirmed invasive TNBC, clinical stage II-III	316 / 158	NA	conclusif	inconclusive 18 % decrease in deaths (OS) (PE) demonstrated 1.5-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE)
la/mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) la/mBC - TNBC - L1 - PDL1 positive
versus nab-paclitaxel
	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	la/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)
versus nab-paclitaxel plus placebo
	nab-paclitaxel plus toripalimab
	TORCHLIGHT PDL 1 positive population, 2024 Nat Med 2024; 30:249-256-. NCT03777579	RCT	la/mBC - TNBC - L1 - PDL1 positive	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	200 / 100	low	conclusif	suggested 38 % decrease in deaths (OS) demonstrated 35 % decrease in progression or deaths (PFS) (PE) The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1-positive patients with metastatic or recurrent TNBC with an acceptable safety profile.
versus paclitaxel
	atezolizumab plus paclitaxel
	IMpassion-131 (PD-L1 > 1%), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	la/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	low	inconclusive	inconclusive 18 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
	pembrolizumab plus SoC
	KEYNOTE-355 (CPS>1), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. NCT02819518	RCT	la/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	la/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) Pembrolizumab–chemotherapy showed a significant and clinically meaningful improvement in progression-free survival versus placebo–chemotherapy among patients with metastatic triple-negative breast cancer with CPS of 10 or more.
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) - (neo)adjuvant (NA) breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - (neo)adjuvant (NA)

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

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

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

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