{"entity":{"id":"paper-gucalp-bicalutamide-ar-positive-tbcrc011-ccr-2013","kind":"paper","name":"Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic breast cancer","aka":[],"tldr":"Screening 424 women with ER-negative breast cancer found androgen receptor in 12%; the prostate drug bicalutamide held the disease stable for six months in 19% of them, the first clinical proof that the LAR subtype can be treated through its receptor.","summary":"TBCRC 011 tested bicalutamide 150 mg daily in ER/PgR-negative advanced breast cancer with central AR immunohistochemistry (over 10% nuclear staining positive). Of 424 patients screened, 12% were AR-positive. The six-month clinical benefit rate was 19% (95% CI 7 to 39) and median progression-free survival 12 weeks; no grade 4 or 5 treatment-related events occurred.","asOf":"2026-09-24","links":[{"label":"Gucalp et al., Clin Cancer Res 2013: bicalutamide in AR-positive, ER-negative metastatic breast cancer (TBCRC 011)","url":"https://doi.org/10.1158/1078-0432.CCR-12-3327"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/23965901/"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["androgen-receptor"],"drugs":["bicalutamide"],"companies":[],"institutions":["mskcc"],"pathways":["ar-signaling"],"terms":["ihc"],"trials":[],"people":["sara-tolaney","hope-rugo"],"bottlenecks":[],"keyPapers":[],"journals":["clinical-cancer-research"],"dependsOn":[],"notes":[],"journal":"Clinical Cancer Research","year":2013,"doi":"10.1158/1078-0432.CCR-12-3327","pmid":"23965901","authors":"Gucalp A, Tolaney S, Isakoff SJ, et al.","paperType":"rct","findings":["AR-positive (over 10% nuclear staining) in 12% of 424 ER/PgR-negative patients.","Six-month clinical benefit rate 19%; median PFS 12 weeks."],"whatItMeans":"It fixes the AR-positive share of ER-negative disease at about one in eight and shows anti-androgens give modest, non-toxic benefit, the rationale for enzalutamide and later CDK4/6 and PI3K combinations in LAR tumours.","caveats":["26 treated patients; single-arm.","AR positivity threshold of 10% differs from the enzalutamide trial's any-staining rule."],"changedPractice":false,"participants":424},"route":"/key-papers/paper-gucalp-bicalutamide-ar-positive-tbcrc011-ccr-2013/","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":"bicalutamide","kind":"drug","name":"Bicalutamide","route":"/drugs/bicalutamide/"}],"institution":[{"id":"mskcc","kind":"institution","name":"Memorial Sloan Kettering Cancer Center","route":"/institutions/mskcc/"}],"pathway":[{"id":"ar-signaling","kind":"pathway","name":"Androgen receptor signalling","route":"/pathways/ar-signaling/"}],"term":[{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}],"person":[{"id":"hope-rugo","kind":"person","name":"Hope S. Rugo","route":"/people/hope-rugo/"},{"id":"sara-tolaney","kind":"person","name":"Sara M. Tolaney","route":"/people/sara-tolaney/"}],"journal":[{"id":"clinical-cancer-research","kind":"journal","name":"Clinical Cancer Research","route":"/journals/clinical-cancer-research/"}]}}