metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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 placebo
	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	OlympiA (BIG 6-13, NSABP B-55) unpublished New England Journal of Medicine NCT02032823	RCT	es-BC - TNBC - NA - all population	olaparib	placebo	patients with human epidermal growth factor receptor 2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)
mBC - TNBC - L1 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population
versus Standard of Care (SoC)
	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-Triple negative (TNBC) - 2nd Line (L2) breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2)
versus Standard of Care (SoC)
	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 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)