{"entity":{"id":"ace-breast-02","kind":"trial","name":"ACE-Breast-02","aka":[],"tldr":"A site-specifically conjugated HER2 ADC beat lapatinib-capecitabine on progression-free survival in China.","summary":"ACE-Breast-02, a Chinese phase 3 sponsored by Zhejiang Medicine and Ambrx and reported in 2024 (it is registered in China rather than on ClinicalTrials.gov; NCT04829604 is the separate US study ACE-Breast-03), showed that ARX788, a HER2 antibody-drug conjugate made with site-specific conjugation, beat lapatinib plus capecitabine on progression-free survival in HER2-positive advanced breast cancer after trastuzumab and a taxane in China. It randomised 441 patients and met its primary endpoint with a clear reduction in the risk of progression; ARX788 uses non-natural amino acid conjugation from Ambrx, now part of Johnson & Johnson, with an MMAF-like payload, and ocular and pulmonary toxicity were noted. OnCo links it to site-specific conjugation and linker chemistry, ARX788 and lapatinib; a marketing application is planned in China with FDA Fast Track status. It is a single phase 3 against an older comparator, so how ARX788 compares with trastuzumab deruxtecan is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ACE-Breast-02 primary publication (PubMed)","url":"https://pubmed.ncbi.nlm.nih.gov/39956849/"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["site-specific-conjugation"],"targets":[],"drugs":["arx788","lapatinib"],"companies":["ambrx"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"HER2+ advanced breast cancer after trastuzumab and taxane (China): ARX788 vs lapatinib + capecitabine","sponsor":"Zhejiang Medicine / Ambrx","result":"PFS 11.3 vs 8.2 months, HR 0.64.","yearReported":2024,"enrolled":441,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"ARX788","value":11.3},{"name":"Lapatinib + capecitabine","value":8.2}],"hr":0.64,"source":"https://pubmed.ncbi.nlm.nih.gov/39956849/"}],"replication":"Single phase 3; ACE-Breast-06 (brain metastases, phase 2) supportive."},"route":"/trials/ace-breast-02/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"technology":[{"id":"site-specific-conjugation","kind":"technology","name":"Site-specific conjugation & linker chemistry","route":"/technologies/site-specific-conjugation/"}],"drug":[{"id":"arx788","kind":"drug","name":"ARX788","route":"/drugs/arx788/"},{"id":"lapatinib","kind":"drug","name":"Lapatinib","route":"/drugs/lapatinib/"}],"company":[{"id":"ambrx","kind":"company","name":"Ambrx","route":"/companies/ambrx/"}]}}