{"entity":{"id":"a-brave","kind":"trial","name":"A-BRAVE","aka":["A-Brave"],"tldr":"A-BRAVE tested a year of the immunotherapy avelumab after standard treatment for high-risk triple-negative breast cancer at Italian and eight British hospitals. Relapse-free survival, the main endpoint, was not significantly improved; a later analysis found the benefit concentrated in tumours rich in immune cells.","summary":"A-BRAVE (NCT02926196) randomised 466 patients (474 registered) with high-risk early triple-negative breast cancer to one year of adjuvant avelumab or observation after standard therapy, in two strata: stratum A after primary surgery and adjuvant chemotherapy (high risk by pathological stage) and stratum B after neoadjuvant chemotherapy without pathological complete response. The co-primary endpoints were disease-free survival overall and in PD-L1-positive patients; the trial did not reach significance for disease-free survival in its 2024 presentation, with a numerical overall survival advantage. The biomarker analysis (Clinical Cancer Research 2026, 387 patients with baseline TILs and 330 with TILs in residual disease) found that higher baseline and residual-disease TILs were independently prognostic, that residual cancer burden was prognostic but did not predict avelumab benefit, and that avelumab improved outcomes only in tumours with baseline TILs of 30 percent or more: in stratum B three-year distant disease-free survival 92.0 versus 58.7 percent (hazard ratio 0.20) in TIL-high against 70.4 versus 70.1 percent (0.92) in TIL-low tumours (interaction p 0.019). Eight UK hospitals recruited. The primary paper's figures are not indexed on Europe PMC, so the disease-free survival hazard ratio is not quoted here.","status":"mixed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02926196","url":"https://clinicaltrials.gov/study/NCT02926196"},{"label":"Dieci et al., Clinical Cancer Research 2026: TILs as a predictor of adjuvant avelumab efficacy in A-BRAVE","url":"https://doi.org/10.1158/1078-0432.CCR-26-0975"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["avelumab"],"companies":[],"institutions":[],"pathways":[],"terms":["tils","rcb","efs"],"trials":["impassion030","swog-s1418","keynote-522"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (registry, 8): Royal United Hospitals Bath, Blackpool Teaching Hospital, Raigmore Hospital Inverness, Royal Free Hospital, St Bartholomew's Hospital, Mount Vernon Cancer Centre, Nottingham City Hospital, Southampton General Hospital."],"nct":"NCT02926196","phase":"3","setting":"High-risk early triple-negative breast cancer after surgery and chemotherapy (adjuvant stratum, or residual disease after neoadjuvant chemotherapy): one year of adjuvant avelumab versus observation, Italy and the United Kingdom","sponsor":"Istituto Oncologico Veneto IRCCS / University of Padova","result":"Primary DFS endpoint not met (figures not indexed); exploratory: avelumab benefit only with baseline TILs 30% or more (stratum B 3-year DDFS 92.0% vs 58.7%, HR 0.20; interaction p 0.019).","yearReported":2024,"enrolled":474,"enrolledBasis":"registry","outcomes":[{"endpoint":"Distant disease-free survival at 3 years, stratum B, baseline TILs 30 percent or more (exploratory)","unit":"%","arms":[{"name":"Avelumab","value":92},{"name":"Observation","value":58.7}],"hr":0.2,"p":"interaction 0.019 (TIL-low tumours 70.4 versus 70.1 percent, hazard ratio 0.92)","source":"https://doi.org/10.1158/1078-0432.CCR-26-0975"}],"replication":"ALEXANDRA/IMpassion030 (adjuvant atezolizumab) was negative; the TIL interaction awaits validation."},"route":"/trials/a-brave/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"avelumab","kind":"drug","name":"Avelumab","route":"/drugs/avelumab/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"rcb","kind":"term","name":"Residual cancer burden (RCB)","route":"/terms/rcb/"},{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"},{"id":"tils","kind":"term","name":"Tumour-infiltrating lymphocytes (TILs)","route":"/terms/tils/"}],"trial":[{"id":"impassion030","kind":"trial","name":"ALEXANDRA / IMpassion030","route":"/trials/impassion030/"},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"},{"id":"swog-s1418","kind":"trial","name":"SWOG S1418 / NRG BR006","route":"/trials/swog-s1418/"}]}}