metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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, placebo
	nab-paclitaxel, toripalimab
	TORCHLIGHT, 2024 Nat Med 2024; 30:249-256-. NCT04085276	RCT	mBC - Triple negative (TNBC) - 1st Line (L1)	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),deaths (OS) suggested 23 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE) statistically significant 73 % increase in SAE (grade 3-4),SAE (grade 3-4)
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)
mBC - TNBC - L1 - all population breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population
versus placebo plus SoC
	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	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
versus Standard of Care (SoC)
	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	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)
	atezolizumab plus paclitaxel
	IMpassion-131 (all population), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	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	NA	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
	capivasertib plus paclitaxel
	PAKT (all population), 2020 J Clin Oncol 2020; 38:423-433-. NCT02423603	RCT	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	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)
	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	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	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)
mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative breast cancer - triple negative metastatic mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive
versus placebo plus SoC
	atezolizumab plus SoC
	IMpassion-132, 2024 Future Oncol 2019; 15:1951-1961 Ann Oncol 2024; 35:630-642-. NCT03371017	RCT	mBC - TNBC - L1 - 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	297 / 298	low	inconclusive	inconclusive 7 % decrease in deaths (OS) (PE) OS was not improved by adding atezolizumab to chemotherapy for rapidly relapsing PD-L1-positive TNBC
	pembrolizumab plus SoC
	KEYNOTE-355 (CPS>1), 2020 Lancet 2020 Dec 5;396(10265):1817-1828. NCT02819518	RCT	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	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) OS results from ESMO Congres 2021
versus Standard of Care (SoC)
	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	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)
	atezolizumab plus paclitaxel
	IMpassion-131 (PD-L1 > 1%), 2020 Ann Oncol 2021; 32:994-1004-. NCT03125902	RCT	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	NA	inconclusive	inconclusive 18 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
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)
es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)
versus non active control
	avelumab alone
	A-Brave, 2024 Journal of Clinical Oncology NCT02926196	RCT	es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)	avelumab	control	Patiennts at High-risk Triple Negative Breast Cancer after completion of standard treatment with curative intent including surgery and neoadjuvant/adjuvant chemotherapy.	-/-	NA	suggested	suggested 34 % decrease in deaths (OS) inconclusive 18 % decrease in RFS/DFS (PE) inconclusive 19 % decrease in RFS/DFS (PE) One year adjuvant avelumab versus control does not significantly improve DFS in high-risk TNBC patients. Nevertheless, the secondary enpoind OS was significanlty improved with avelumab vs control.
es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population
versus carboplatin plus nab-paclitaxel
	atezolizumab plus carboplatin plus nab-paclitaxel
	NeoTRIPaPDLA unpublished Ann Oncol 2022; 33:534-543-. NCT02620280	RCT	es-BC - TNBC - NA - all population	atezolizumab plus carboplatine plus nab-paclitaxel	carboplatine plus nab-paclitaxel	Neoadjuvant Therapy in TRIPle Negative Breast Cancer (early or locally advanced)	88 / 86	NA	inconclusive	no statistically significant result
versus paclitaxel followed by doxorubicin plus cyclophosphamide
	atezolizumab based treatment, paclitaxel followed by doxorubicin plus cyclophosphamide
	ALEXANDRA/IMpassion-030, 2024 Journal of Clinical Oncology European Journal of Cancer Annals of Oncology NCT03498716	RCT	es-BC - TNBC - NA - all population	atezolizumab plus chemotherapy	chemotherapy	Patients with newly diagnosed Stage II-III (es) primary invasive Breast cancer (BC) that is of triple negative phenotype and who were to be treated with adjuvant systemic chemotherapy following definitive surgery,	1101 / 1098	NA	inconclusive	inconclusive 11 % increase in iDFS,iDFS (PE) statistically significant 81 % increase in SAE (any grade),SAE (any grade) At the final analysis, the addition of atezo to adjuvant anthracycline- and taxane-based chemo did not improve iDFS in the ITT population of stage II-III TNBC or in any of the subgroups interrogated. Safety data remain consistent with the known profile of atezo in early TNBC.
versus placebo
	durvalumab alone
	GeparNuevo, 2019 Ann. Oncol. 2019; : Ann Oncol 2022; 33:1149-1158-. NCT02685059	RCT	es-BC - TNBC - NA - all population	durvalumab followed by nab-paclitaxel	placebo followed by nab-paclitaxel	Patients with previously untreated uni- or bilateral primary, non-metastatic invasive TNBC with a tumour of at least 2 cm (cT2-cT4a-d) treated as neoadjuvant	88 / 86	some concern	suggested	suggested 76 % decrease in deaths (OS) (extension) inconclusive 45 % increase in pCR (PE)
	olaparib
	OlympiA (BIG 6-13, NSABP B-55) unpublished New England Journal of Medicine NCT02032823	RCT	es-BC - TNBC - NA - all population	olaparib	placebo	patients with human epidermal growth factor receptor 2 (HER2)–negative early breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants and high-risk clinicopathological factors	921 / 915	NA	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 42 % decrease in iDFS (PE)
	pembrolizumab alone
	KEYNOTE-522, 2020 N. Engl. J. Med. 2020; 382:810-821 N Engl J Med 2022; 386:556-567-. JAMA Netw Open 2023; 6:e2342107-. Ann Oncol 2024; 35:429-436-. J Natl Cancer Inst 2024; 116:1654-1663-. NCT03036488	RCT	es-BC - TNBC - NA - all population	pembrolizumab	placebo	previously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase;	784 / 390	low	conclusif	demonstrated 12.6-fold increase in pCR (PE) suggested 37 % decrease in events or deaths (EFS) (PE)
versus placebo plus SoC
	atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide
	IMpassion-031 (all population), 2020 Lancet 2020 Oct 10;396(10257):1090-1100. Jpn J Clin Oncol 2022; 52:1124-1133-. NCT03197935	RCT	es-BC - TNBC - NA - all population	Atezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	placebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	neoadjuvant setting in participants with early stage (stage II-III) triple negative breast cancer	165 / 168	low	conclusif	demonstrated 95 % increase in pCR (PE)
es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive
versus placebo plus SoC
	atezolizumab plus nab-paclitxel followed by doxorubicin plus cyclophosphamide
	IMpassion-031 (PDL1>1%), 2020 Lancet 2020 Oct 10;396(10257):1090-1100. NCT03197935	RCT	es-BC - TNBC - NA - PDL1 positive	Atezolizumab plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	placebo plus nab-paclitaxel followed by doxorubicin and cyclophosphamide with filgrastim or pegfilgrastim support	neoadjuvant setting in participants with early stage (stage II III) triple negative breast cancer with PDL1 >1%	78 / 76	low	suggested	suggested 1.2-fold increase in pCR (PE)

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

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

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

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

es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA)

es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population

es-BC - TNBC - NA - PDL1 positive breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - PDL1 positive