{"entity":{"id":"evera","kind":"trial","name":"evERA","aka":[],"tldr":"In evERA, pairing an oral SERD with everolimus after CDK4/6 failure delayed progression by more than three months, and by four and a half months in ESR1-mutant tumours.","summary":"evERA, trial NCT05306340 sponsored by Roche and Genentech and reported at ESMO 2025, showed that pairing the oral SERD giredestrant with everolimus after CDK4/6 inhibitor failure in ER-positive, HER2-negative advanced breast cancer delayed progression by more than three months, and by about four and a half months in ESR1-mutant tumours. It randomised 320 women to giredestrant or standard endocrine therapy, each with everolimus, and met its primary progression-free survival endpoints in both the intention-to-treat and ESR1-mutant populations, after which the FDA accepted a new drug application for the ESR1-mutant indication in February 2026. OnCo links it to the oestrogen receptor, giredestrant, everolimus and exemestane, and the result is consistent with BOLERO-2 for the everolimus backbone. Whether the combination beats an oral SERD alone is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05306340","url":"https://clinicaltrials.gov/study/NCT05306340"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy"],"targets":["estrogen-receptor"],"drugs":["giredestrant","everolimus"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05306340","phase":"3","setting":"ER+/HER2- advanced breast cancer after CDK4/6 inhibitor: giredestrant + everolimus vs standard endocrine therapy + everolimus","sponsor":"Roche / Genentech","result":"PFS HR 0.56 (ITT); HR 0.38 (ESR1-mutant).","started":"2022-08-03","startedType":"actual","yearReported":2025,"enrolled":320,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 373 participants (actual); 320 is the randomised population presented at ESMO 2025 and quoted in the summary. No journal paper is indexed on Europe PMC yet, so the figure has not been checked against a primary publication.","outcomes":[{"endpoint":"Progression-free survival (ITT)","primary":true,"unit":"months","arms":[{"name":"Giredestrant + everolimus","value":8.77},{"name":"Standard ET + everolimus","value":5.49}],"hr":0.56,"ci":[0.44,0.71],"p":"<0.0001","source":"https://www.roche.com/media/releases/med-cor-2025-10-18"},{"endpoint":"Progression-free survival (ESR1-mutant)","primary":true,"unit":"months","arms":[{"name":"Giredestrant + everolimus","value":9.99},{"name":"Standard ET + everolimus","value":5.45}],"hr":0.38,"ci":[0.27,0.54],"p":"<0.0001"}],"replication":"Consistent with BOLERO-2 (everolimus + exemestane) as the backbone and with other oral SERDs in ESR1-mutant disease."},"route":"/trials/evera/","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/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"}],"target":[{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"}],"drug":[{"id":"everolimus","kind":"drug","name":"Everolimus","route":"/drugs/everolimus/"},{"id":"exemestane","kind":"drug","name":"Exemestane","route":"/drugs/exemestane/"},{"id":"giredestrant","kind":"drug","name":"Giredestrant","route":"/drugs/giredestrant/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}