metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
mBC - TNBC - L1 - all population breast cancer - triple negative 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. ESMO Congres 2021 N Engl J Med 2022 Jul 21;387(3):217-226. 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 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population