{"entity":{"id":"paper-denkert-her2-low-pooled-neoadjuvant-lancet-oncol-2021","kind":"paper","name":"Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials","aka":[],"tldr":"Among 2,310 patients in four German neoadjuvant trials, 34% of hormone receptor-negative tumours were HER2-low; they responded to chemotherapy as often as HER2-zero tumours but had better three-year survival.","summary":"2,310 patients with HER2-non-amplified primary breast cancer treated in GeparSepto, GeparOcto, GeparX and GAIN-2 with prospective central HER2 testing were pooled. 1,098 (47.5%) were HER2-low-positive (IHC 1+ or 2+/ISH-negative) and 1,212 HER2-zero; 703 (64.0%) of HER2-low versus 445 (36.7%) of HER2-zero tumours were hormone receptor-positive, so 395 of 1,162 hormone receptor-negative tumours (34.0%) were HER2-low. pCR was lower in HER2-low tumours overall (29.2% versus 39.0%) and in the HR-positive subgroup but not in the HR-negative subgroup (50.1% versus 48.0%). HER2-low patients had longer three-year disease-free (83.4% versus 76.1%) and overall survival (91.6% versus 85.8%), with the differences seen in HR-negative tumours (DFS 84.5% versus 74.4%; OS 90.2% versus 84.3%).","asOf":"2026-09-24","links":[{"label":"Denkert et al., Lancet Oncol 2021: HER2-low-positive disease in 2,310 patients from four neoadjuvant trials","url":"https://doi.org/10.1016/S1470-2045(21)00301-6"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34252375/"}],"tags":[],"related":["her2-low-ihc"],"cancers":["tnbc","tnbc-early","her2-low-metastatic-breast-cancer"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["gbg"],"institutions":[],"pathways":[],"terms":["her2-low","pcr"],"trials":[],"people":["carsten-denkert","sibylle-loibl"],"bottlenecks":[],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2021,"doi":"10.1016/S1470-2045(21)00301-6","pmid":"34252375","authors":"Denkert C, Seither F, Schneeweiss A, et al.","paperType":"observational","findings":["HER2-low in 395 of 1,162 hormone receptor-negative tumours, 34.0%.","pCR in HR-negative disease 50.1% HER2-low versus 48.0% HER2-zero.","HR-negative HER2-low: three-year DFS 84.5% versus 74.4%, OS 90.2% versus 84.3%."],"whatItMeans":"The trial-grade HER2-low share for TNBC is about a third, and the survival difference hints that HER2-zero triple-negative disease is the more aggressive group.","caveats":["Pooled trial populations with different regimens.","Survival data available for 1,694 patients."],"changedPractice":false,"participants":2310},"route":"/key-papers/paper-denkert-her2-low-pooled-neoadjuvant-lancet-oncol-2021/","neighbours":{"biomarker":[{"id":"her2-low-ihc","kind":"biomarker","name":"HER2-low (IHC 1+ or IHC 2+/ISH-negative)","route":"/biomarkers/her2-low-ihc/"}],"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"her2-low-metastatic-breast-cancer","kind":"cancer","name":"HER2-low and HER2-ultralow metastatic breast cancer","route":"/cancers/her2-low-metastatic-breast-cancer/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"gbg","kind":"company","name":"German Breast Group (GBG)","route":"/companies/gbg/"}],"term":[{"id":"her2-low","kind":"term","name":"HER2-low and HER2-ultralow","route":"/terms/her2-low/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}],"person":[{"id":"carsten-denkert","kind":"person","name":"Carsten Denkert","route":"/people/carsten-denkert/"},{"id":"sibylle-loibl","kind":"person","name":"Sibylle Loibl","route":"/people/sibylle-loibl/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}