metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
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)
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	OlympiA (BIG 6-13, NSABP B-55) unpublished New England Journal of Medicine NCT02032823	RCT	es-BC - TNBC - NA - all population	olaparib	placebo	patients with human epidermal growth factor receptor 2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)

Study

study type

Pathology

Patients

sample sizes

ROB

Results

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

inconclusive 10 % decrease in deaths (OS) (PE)
demonstrated 42 % decrease in progression or deaths (PFS) (PE)

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

demonstrated 32 % decrease in deaths (OS) (PE)
demonstrated 42 % decrease in iDFS (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

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