{"entity":{"id":"nct05346224","kind":"trial","name":"A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing HLX11 in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, active and no longer recruiting.","summary":"A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer is a phase 3 interventional study registered as NCT05346224, led by Shanghai Henlius Biotech, and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer. Planned enrolment is 900 participants (estimated). The study started in 2022-04-25 and primary completion is expected in 2024-05-15. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05346224","url":"https://clinicaltrials.gov/study/NCT05346224"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["hlx11"],"companies":["henlius"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05346224","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer","sponsor":"Shanghai Henlius Biotech","started":"2022-04-25","startedType":"actual","enrolled":900,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05346224/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"hlx11","kind":"drug","name":"HLX11","route":"/drugs/hlx11/"}],"company":[{"id":"henlius","kind":"company","name":"Shanghai Henlius Biotech","route":"/companies/henlius/"}]}}