metaEvidence evidence</span> <span>COVID-19


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
breast cancer - triple negative breast cancer - triple negative
versus Standard of Care (SoC)
	durvalumab alone
	Saphir02 Breast-Immuno, 2021 Nat Med 2021; 27:250-255-. NCT02299999	RCT	breast cancer - triple negative	durvalumab	chemotherapy	patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after initial chemotherapy (maintenance chemotherapy).	131 / 68	some concern	inconclusive	inconclusive 40 % increase in progression or deaths (PFS) (PE) Maintenance chemotherapy was more effective than durvalumab in patients with hormone receptor-positive and Her2-negative disease.
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 nab-paclitaxel
	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)

Study

study type

Pathology

T1

T0

Patients

sample sizes

ROB

Results

NCT02299999

RCT

breast cancer - triple negative

durvalumab

chemotherapy

patients with human epidermal growth factor receptor type 2 (Her2)-negative metastatic breast cancer whose disease did not progress after initial chemotherapy (maintenance chemotherapy).

131 / 68

inconclusive 40 % increase in progression or deaths (PFS) (PE)

Maintenance chemotherapy was more effective than durvalumab in patients with hormone receptor-positive and Her2-negative disease.

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

suggested 76 % decrease in deaths (OS) (extension)
inconclusive 45 % increase in pCR (PE)

breast cancer - triple negative breast cancer - triple negative

versus Standard of Care (SoC)

durvalumab alone

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 nab-paclitaxel

durvalumab alone