{"entity":{"id":"cleopatra","kind":"trial","name":"CLEOPATRA","aka":[],"tldr":"Adding a second HER2 antibody, pertuzumab, extended survival by 16 months, the largest gain ever seen in metastatic breast cancer at the time.","summary":"CLEOPATRA, trial NCT00567190 sponsored by Roche and Genentech and reported in 2011, showed that adding a second HER2 antibody, pertuzumab, to trastuzumab and docetaxel as first-line treatment for HER2-positive metastatic breast cancer extended survival by more than a year, the largest gain ever seen in metastatic breast cancer at the time. It randomised 808 women, met its primary progression-free survival endpoint, and its final survival analysis and eight-year landmark confirmed a durable benefit, defining the first-line regimen known as THP until DESTINY-Breast09 in 2025. OnCo links it to HER2 as a target, pertuzumab, trastuzumab, docetaxel, the dual HER2 blockade term, Sandra M. Swain, Javier Cortés and Georgetown Lombardi, and the dual blockade benefit was replicated in NeoSphere and APHINITY. Whether antibody-drug conjugates now displace THP entirely is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00567190","url":"https://clinicaltrials.gov/study/NCT00567190"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["her2"],"drugs":["pertuzumab","trastuzumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sandra-swain","javier-cortes"],"bottlenecks":[],"keyPapers":["paper-cleopatra-n-engl-j-med-2012","paper-cleopatra-lancet-oncol-2013-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00567190","phase":"3","setting":"First-line HER2+ metastatic breast cancer: pertuzumab + trastuzumab + docetaxel vs placebo + trastuzumab + docetaxel","sponsor":"Roche / Genentech","result":"OS 57.1 vs 40.8 months, HR 0.69.","started":"2008-02-12","startedType":"actual","yearReported":2011,"enrolled":808,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Pertuzumab + trastuzumab + docetaxel","n":402,"value":18.7},{"name":"Placebo + trastuzumab + docetaxel","n":406,"value":12.4}],"hr":0.68,"ci":[0.58,0.8],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1113216"},{"endpoint":"Overall survival (final)","unit":"months","arms":[{"name":"Pertuzumab arm","value":57.1},{"name":"Placebo arm","value":40.8}],"hr":0.69,"ci":[0.58,0.82],"source":"https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30863-0/fulltext"}],"replication":"Dual blockade benefit replicated in neoadjuvant (NeoSphere pCR) and adjuvant (APHINITY) settings."},"route":"/trials/cleopatra/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"person":[{"id":"javier-cortes","kind":"person","name":"Javier Cortés","route":"/people/javier-cortes/"},{"id":"sandra-swain","kind":"person","name":"Sandra M. Swain","route":"/people/sandra-swain/"}],"paper":[{"id":"paper-cleopatra-n-engl-j-med-2012","kind":"paper","name":"Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer","route":"/key-papers/paper-cleopatra-n-engl-j-med-2012/"},{"id":"paper-cleopatra-lancet-oncol-2013-update","kind":"paper","name":"Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study","route":"/key-papers/paper-cleopatra-lancet-oncol-2013-update/"}],"term":[{"id":"dual-her2-blockade","kind":"term","name":"Dual HER2 blockade","route":"/terms/dual-her2-blockade/"}],"institution":[{"id":"georgetown-lombardi","kind":"institution","name":"Georgetown Lombardi Comprehensive Cancer Center","route":"/institutions/georgetown-lombardi/"}]}}