{"entity":{"id":"paper-traina-enzalutamide-ar-tnbc-jco-2018","kind":"paper","name":"Enzalutamide for the treatment of androgen receptor-expressing triple-negative breast cancer","aka":[],"tldr":"Enzalutamide gave clinical benefit at 16 weeks to a quarter of women with androgen receptor-expressing triple-negative breast cancer, a third among those with 10% or more staining, with fatigue the only common severe side effect.","summary":"Phase 2 study of enzalutamide 160 mg daily in locally advanced or metastatic AR-positive TNBC (nuclear AR staining above 0% by a breast-optimised assay). Of 118 enrolled, 78 were evaluable (10% or more nuclear AR with a post-baseline assessment). Clinical benefit at 16 weeks was 25% (intention-to-treat) and 33% (evaluable); median progression-free survival 2.9 and 3.3 months; median overall survival 12.7 and 17.6 months. Fatigue was the only grade 3 or higher related event above 2%.","asOf":"2026-09-24","links":[{"label":"Traina et al., J Clin Oncol 2018: enzalutamide in AR-expressing TNBC","url":"https://doi.org/10.1200/JCO.2016.71.3495"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29373071/"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["androgen-receptor"],"drugs":["enzalutamide"],"companies":[],"institutions":[],"pathways":["ar-signaling"],"terms":[],"trials":[],"people":["peter-schmid","eric-winer"],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2018,"doi":"10.1200/JCO.2016.71.3495","pmid":"29373071","authors":"Traina TA, Miller K, Yardley DA, et al.","paperType":"rct","findings":["Clinical benefit at 16 weeks 25% (ITT) and 33% (AR 10% or more).","Median overall survival 12.7 (ITT) and 17.6 months (evaluable)."],"whatItMeans":"Enzalutamide works modestly in AR-positive TNBC and is the reference for the LAR subtype's therapy implication; the AR threshold used for eligibility changes who counts as positive.","caveats":["Single-arm phase 2; the phase 3 was not pursued.","A companion gene signature (PREDICT AR) was explored but is not validated."],"changedPractice":false,"participants":118},"route":"/key-papers/paper-traina-enzalutamide-ar-tnbc-jco-2018/","neighbours":{"cancer":[{"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/"}],"target":[{"id":"androgen-receptor","kind":"target","name":"Androgen receptor","route":"/targets/androgen-receptor/"}],"drug":[{"id":"enzalutamide","kind":"drug","name":"Enzalutamide","route":"/drugs/enzalutamide/"}],"pathway":[{"id":"ar-signaling","kind":"pathway","name":"Androgen receptor signalling","route":"/pathways/ar-signaling/"}],"person":[{"id":"eric-winer","kind":"person","name":"Eric P. Winer","route":"/people/eric-winer/"},{"id":"peter-schmid","kind":"person","name":"Peter Schmid","route":"/people/peter-schmid/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}