{"entity":{"id":"gepardouze","kind":"trial","name":"GeparDouze / NSABP B-59","aka":["NSABP B-59","GBG 96","GeparDouze"],"tldr":"GeparDouze, the largest neoadjuvant immunotherapy trial in triple-negative breast cancer, found that adding atezolizumab to chemotherapy before and after surgery did not significantly reduce relapses (a 3.3-point gain at four years that missed statistical significance), unlike pembrolizumab in KEYNOTE-522.","summary":"NSABP B-59/GeparDouze (NCT03281954) randomised 1,550 patients (773 atezolizumab, 777 placebo) with stage II to III triple-negative breast cancer to sequential taxane, carboplatin and anthracycline neoadjuvant chemotherapy with atezolizumab or placebo, continued after surgery. The primary endpoint, event-free survival, was not significantly improved (hazard ratio 0.80, 95 percent confidence interval 0.62 to 1.03, stratified log-rank p 0.083; four-year rates differed by 3.3 points); the overall survival hazard ratio was 0.86 (0.62 to 1.19) with a 0.7-point four-year difference. A prespecified subgroup analysis suggested benefit in patients with clinical nodal involvement (interaction p 0.039), and an exploratory mRNA analysis pointed to basal-like immune-activated tumours. Grade 3 or worse treatment-emergent adverse events were 75.3 versus 73.4 percent and immune-related adverse events 27.6 versus 11.4 percent; 25.5 percent discontinued atezolizumab in the neoadjuvant phase against 18.8 percent for placebo. Published in Nature Medicine in 2026, the trial leaves pembrolizumab as the only checkpoint inhibitor with an early-stage triple-negative licence.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03281954","url":"https://clinicaltrials.gov/study/NCT03281954"},{"label":"Geyer, Loibl et al., Nature Medicine 2026: atezolizumab in early triple-negative breast cancer, NSABP B-59/GeparDouze","url":"https://doi.org/10.1038/s41591-026-04565-6"}],"tags":[],"related":[],"cancers":["tnbc","tnbc-early"],"sections":[],"technologies":["checkpoint-inhibitor","platinum","cytotoxic-chemotherapy"],"targets":[],"drugs":["atezolizumab","carboplatin","paclitaxel","doxorubicin","epirubicin","cyclophosphamide"],"companies":["roche-genentech","gbg"],"institutions":[],"pathways":[],"terms":["efs","irae","tils"],"trials":["keynote-522","neotrip","impassion030","impassion031"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03281954","phase":"3","setting":"Stage II to III triple-negative breast cancer: neoadjuvant taxane, carboplatin and anthracycline chemotherapy with atezolizumab or placebo, then adjuvant atezolizumab or placebo, United States, Canada and Germany","sponsor":"NSABP Foundation / German Breast Group, with Genentech and Roche","result":"EFS HR 0.80 (0.62 to 1.03), p 0.083, not significant; OS HR 0.86 (0.62 to 1.19).","yearReported":2026,"enrolled":1550,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (four-year difference 3.3 points)","primary":true,"arms":[{"name":"Atezolizumab + chemotherapy","n":773},{"name":"Placebo + chemotherapy","n":777}],"hr":0.8,"ci":[0.62,1.03],"p":"0.083","source":"https://doi.org/10.1038/s41591-026-04565-6"},{"endpoint":"Overall survival (four-year difference 0.7 points)","arms":[{"name":"Atezolizumab + chemotherapy"},{"name":"Placebo + chemotherapy"}],"hr":0.86,"ci":[0.62,1.19],"source":"https://doi.org/10.1038/s41591-026-04565-6"}],"replication":"Consistent with NeoTRIP (no pCR gain) and ALEXANDRA/IMpassion030 (adjuvant, futile); discordant with KEYNOTE-522 (pembrolizumab, EFS HR 0.63)."},"route":"/trials/gepardouze/","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":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"epirubicin","kind":"drug","name":"Epirubicin","route":"/drugs/epirubicin/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"company":[{"id":"gbg","kind":"company","name":"German Breast Group (GBG)","route":"/companies/gbg/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"efs","kind":"term","name":"Event-free / disease-free survival (EFS, DFS, iDFS, RFS)","route":"/terms/efs/"},{"id":"irae","kind":"term","name":"Immune-related adverse events (irAEs)","route":"/terms/irae/"},{"id":"tils","kind":"term","name":"Tumour-infiltrating lymphocytes (TILs)","route":"/terms/tils/"}],"trial":[{"id":"impassion030","kind":"trial","name":"ALEXANDRA / IMpassion030","route":"/trials/impassion030/"},{"id":"impassion031","kind":"trial","name":"IMpassion031","route":"/trials/impassion031/"},{"id":"keynote-522","kind":"trial","name":"KEYNOTE-522","route":"/trials/keynote-522/"},{"id":"neotrip","kind":"trial","name":"NeoTRIP (NeoTRIPaPDL1)","route":"/trials/neotrip/"}]}}