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(Sub-Study C)","nct":"NCT06125522","phase":"1/2","status":"active"}],"pathways":["breast-cancer-signalling","chemical-carcinogenesis-receptor-activation","endometrial-cancer-signalling","er-signaling","cell-cycle-engine-cdks","ubiquitin-proteasome-system"],"companies":["arvinas","astrazeneca","eli-lilly","eurofarma","ge-healthcare","gtx","guardant-health","kyowa-kirin","linnaeus-therapeutics","menarini","novartis","pathos-ai","pfizer","roche-genentech"],"keyPapers":["paper-natalee-nejm-2024","paper-monarche-jco-2020","paper-ibis-i-tamoxifen-lancet-oncol-2015","paper-protac-concept-sakamoto-pnas-2001"],"hotspots":[{"label":"Y537S / Y537N / Y537C","position":537,"kind":"resistance","frequency":"ESR1 mutations arise in roughly 30 to 40% of tumours progressing on aromatase inhibitors; Y537S and D538G dominate","drugs":["elacestrant","imlunestrant","camizestrant","vepdegestrant","giredestrant"]},{"label":"D538G","position":538,"kind":"resistance","drugs":["elacestrant","imlunestrant","camizestrant","vepdegestrant"]},{"label":"E380Q / L536 / S463P","position":380,"kind":"resistance","drugs":["elacestrant","camizestrant"]}],"openQuestions":[{"id":"esr1-ctdna-switch","question":"Does switching to an oral SERD when ESR1 mutations first appear in ctDNA, before progression, improve overall survival?","stage":"clinical","actor":"clinic","source":{"label":"SERENA-6 (ClinicalTrials.gov)","url":"https://clinicaltrials.gov/study/NCT04964934"}}],"assays":[{"id":"guardant360-cdx","name":"Guardant360 CDx","cutoff":"Per companion claim: EGFR (osimertinib), EGFR exon 20 insertions (amivantamab), KRAS G12C (sotorasib), ESR1 mutations (elacestrant), ERBB2 mutations (zongertinib); negative plasma reflexes to tissue"},{"id":"oncotype-dx","name":"Oncotype DX Breast Recurrence Score","cutoff":"Recurrence score 0 to 25 (postmenopausal, node-negative or 1 to 3 nodes): chemotherapy can be omitted (TAILORx, RxPONDER); premenopausal 16 to 25: benefit from chemotherapy"}],"resistance":[{"class":"cdk46-endocrine","mechanism":"ESR1 ligand-binding-domain mutations","category":"on-target"},{"class":"cdk46-endocrine","mechanism":"RB1 loss","category":"bypass"},{"class":"cdk46-endocrine","mechanism":"Cyclin E / CDK2 activation","category":"bypass"},{"class":"cdk46-endocrine","mechanism":"PI3K/AKT/mTOR activation","category":"bypass"}],"licence":"CC BY-NC 4.0, attribution to OnCo (https://onco.cc); commercial use needs a licence"}