{"entity":{"id":"embraca","kind":"trial","name":"EMBRACA","aka":[],"tldr":"EMBRACA showed that the PARP inhibitor talazoparib delays progression by about three months compared with chemotherapy in women with an inherited BRCA mutation and advanced breast cancer, with better quality of life but no gain in overall survival.","summary":"EMBRACA, trial NCT01945775 sponsored by Pfizer through Medivation and published in the New England Journal of Medicine in 2018, randomised 431 patients with a germline BRCA1 or BRCA2 mutation and HER2-negative advanced breast cancer to talazoparib once daily or the physician's choice of capecitabine, eribulin, gemcitabine or vinorelbine. Progression-free survival rose from 5.6 to 8.6 months (hazard ratio 0.54), the response rate more than doubled and patient-reported quality of life deteriorated later on talazoparib, while anaemia needing transfusion was more common. The final overall survival analysis in 2020 showed no significant difference (hazard ratio 0.85), which the authors attributed partly to later PARP inhibitor and platinum use in the control arm. It led to the October 2018 approval of talazoparib and, with OlympiAD, established PARP inhibitors as an alternative to chemotherapy in BRCA carriers. Whether combining PARP inhibition with immunotherapy or antibody-drug conjugates adds to it is the open question.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01945775","url":"https://clinicaltrials.gov/study/NCT01945775"},{"label":"Litton et al., EMBRACA (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1802905"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","tnbc-metastatic","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca","parp"],"drugs":["talazoparib","capecitabine","eribulin","gemcitabine","vinorelbine"],"companies":[],"institutions":[],"pathways":[],"terms":["gbrca-mutation"],"trials":[],"people":["jennifer-litton"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01945775","phase":"3","setting":"Germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer: talazoparib vs physician's choice chemotherapy","sponsor":"Pfizer (Medivation)","result":"PFS 8.6 vs 5.6 months, HR 0.54; OS HR 0.85, not significant.","yearReported":2018,"enrolled":431,"outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Talazoparib","n":287,"value":8.6},{"name":"Chemotherapy","n":144,"value":5.6}],"hr":0.54,"ci":[0.41,0.71],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1802905"},{"endpoint":"Overall survival (final)","arms":[{"name":"Talazoparib"},{"name":"Chemotherapy"}],"hr":0.85,"ci":[0.67,1.07],"source":"https://doi.org/10.1016/j.annonc.2020.08.2098"}],"replication":"Consistent with OlympiAD; neither PARP inhibitor trial showed an overall survival gain."},"route":"/trials/embraca/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"},{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"eribulin","kind":"drug","name":"Eribulin","route":"/drugs/eribulin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"talazoparib","kind":"drug","name":"Talazoparib","route":"/drugs/talazoparib/"},{"id":"vinorelbine","kind":"drug","name":"Vinorelbine","route":"/drugs/vinorelbine/"}],"term":[{"id":"gbrca-mutation","kind":"term","name":"Germline BRCA mutation (gBRCA)","route":"/terms/gbrca-mutation/"}],"person":[{"id":"jennifer-litton","kind":"person","name":"Jennifer K. Litton","route":"/people/jennifer-litton/"}]}}