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 lapatinib plus epirubicin and cyclophosphamide followed by docetaxel
	trastuzumab plus epirubicin and cyclophosphamide followed by docetaxel
	GeparQuinto, 2012 J Clin Oncol 2018; 36:1308-1316-. Lancet Oncol 2012; 13:135-44-. NCT00567554	RCT	es-BC - HER2 positive - (neo)adjuvant (NA)	trastuzumab plus epirubicin and cyclophosphamide followed by docetaxel	lapatinib plus epirubicin and cyclophosphamide followed by docetaxel	Women with previouscly untreated unilateral or bilateral primary invasive breast carcinoma, with HER2-positive	309 / 311	NA	conclusif	demonstrated 48 % increase in pCR (PE)
versus paclitaxel followed by doxorubicin plus cyclophosphamide, pertuzumab plus trastuzumab, placebo
	paclitaxel followed by doxorubicin plus cyclophosphamide, pertuzumab plus trastuzumab
	IMpassion-050, 2022 J Clin Oncol 2022; 40:2946-2956-. European Society for Medical Oncology NCT03726879	RCT	es-BC - HER2 positive - (neo)adjuvant (NA)	Atezolizumab plus SOC	Placebo plus SOC	Patients ≥ 18 years old with a primary tumor of > 2 cm, positive lymph node status and histologically confirmed Early Her2-Positive Breast Cancer	226 / 228	low	inconclusive	inconclusive 1 % decrease in pCR ,pCR (PE) inconclusive 33 % decrease in pCR ,pCR (PE) Atezolizumab with neoadjuvant dose-dense doxorubicin/cyclophosphamide–paclitaxel and PH for high-risk, HER2-positive early breast cancer did not increase pCR rates versus placebo in the ITT or PD-L1–positive populations
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)
	trastuzumab emtasine plus endocrine therapy
	Harbeck (TDM1 plus ET), 2017 J Clin Oncol 2017; 35:3046-3054-. NCT01817452	RCT	es-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA)	trastuzumab emtasine plus endocrine therapy	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	-/-	NA	suggested	suggested 3.0-fold increase in pCR (PE)

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