metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
es-BC - HER2 positive - (neo)adjuvant (NA) breast cancer - HER2-positive es-BC - HER2 positive - (neo)adjuvant (NA)
versus trastuzumab
	trastuzumab emtansine
	KATHERINE, 2019 N Engl J Med 2019; 380:617-628-. Ann Oncol 2021; 32:1005-1014-. Cancer 2020; 126:3132-3139-. Breast Cancer Res Treat 2021; 187:759-768-. NCT01772472	RCT	es-BC - HER2 positive - (neo)adjuvant (NA)	trastuzumab emtasine (T-DM1)	trastuzumab	Patients had histologically confirmed, HER2-positive, nonmetastatic, invasive primary breast cancer and if residual invasive disease after completion of taxane-based neoadjuvant chemotherapy ad and had to have completed at least six cycles (16 weeks) of a conventional preoperative chemotherapy regimen containing a minimum of 9 weeks of taxane-based therapy and 9 weeks of trastuzumab therapy.	743 / 743	high	conclusif	inconclusive 30 % decrease in deaths (OS) (PE) demonstrated 50 % decrease in iDFS (PE)
versus trastuzumab plus endocrine therapy
	trastuzumab emtansine
	Harbeck (TDM-1), 2017 J Clin Oncol 2017; 35:3046-3054-.	RCT	es-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA)	trastuzumab emtasine	trastuzumab plus endocrine therapy	Women older than 18yr with histologically confirmed unilateral primary BC, no evidence of distant metastasis, ER and/or PR-positive and HER2-positive who were candidates for neoadjuvant chemotherapy were eligible	119 / 129	NA	suggested	suggested 2.9-fold increase in pCR (PE)
la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)
versus lapatinib plus capecitabine
	trastuzumab emtansine
	EMILIA, 2012 N Engl J Med 2012;367:1783-91 Lancet Oncol 2017; 18: 732–42 NCT00829166	RCT	la/mBC - HER2 positive - 2nd Line (L2)	trastuzumab emtansine	lapatinib plus capecitabine	patients with HER2-positive unresectable, locally advanced or metastatic breast cancer, who had previously been treated with trastuzumab and a taxane.	495 / 496	some concern	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 35 % decrease in progression or deaths (PFS) (PE) suggested 25 % decrease in deaths (OS) (extension) demonstrated 73 % increase in objective responses (ORR) (PE)

Study

study type

Pathology

Patients

sample sizes

ROB

Results

NCT01772472

RCT

es-BC - HER2 positive - (neo)adjuvant (NA)

trastuzumab emtasine (T-DM1)

trastuzumab

Patients had histologically confirmed, HER2-positive, nonmetastatic, invasive primary breast cancer and if residual invasive disease after completion of taxane-based neoadjuvant chemotherapy ad and had to have completed at least six cycles (16 weeks) of a conventional preoperative chemotherapy regimen containing a minimum of 9 weeks of taxane-based therapy and 9 weeks of trastuzumab therapy.

743 / 743

inconclusive 30 % decrease in deaths (OS) (PE)
demonstrated 50 % decrease in iDFS (PE)

RCT

es-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA)

trastuzumab emtasine

trastuzumab plus endocrine therapy

Women older than 18yr with histologically confirmed unilateral primary BC, no evidence of distant metastasis, ER and/or PR-positive and HER2-positive who were candidates for neoadjuvant chemotherapy were eligible

119 / 129

suggested 2.9-fold increase in pCR (PE)

NCT00829166

RCT

la/mBC - HER2 positive - 2nd Line (L2)

trastuzumab emtansine

lapatinib plus capecitabine

patients with HER2-positive unresectable, locally advanced or metastatic breast cancer, who had previously been treated with trastuzumab and a taxane.

495 / 496

demonstrated 32 % decrease in deaths (OS) (PE)
demonstrated 35 % decrease in progression or deaths (PFS) (PE)
suggested 25 % decrease in deaths (OS) (extension)
demonstrated 73 % increase in objective responses (ORR) (PE)

es-BC - HER2 positive - (neo)adjuvant (NA) breast cancer - HER2-positive es-BC - HER2 positive - (neo)adjuvant (NA)

versus trastuzumab

trastuzumab emtansine

versus trastuzumab plus endocrine therapy

trastuzumab emtansine

la/mBC - HER2 positive - 2nd Line (L2) breast cancer - HER2-positive la/mBC - HER2 positive la/mBC - HER2 positive - 2nd Line (L2)

versus lapatinib plus capecitabine

trastuzumab emtansine