{"entity":{"id":"nct03262935","kind":"trial","name":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial of Trastuzumab duocarmazine, Lapatinib, Capecitabine, Trastuzumab, Vinorelbine and Eribulin in Breast cancer, run by Byondis B.V., completed.","summary":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT03262935 by Byondis B.V., with 437 participants recorded, started 2017-12-15 and reaching its primary completion in 2021-03-31. Interventions recorded: (vic-)trastuzumab duocarmazine, Physician's choice. Conditions recorded: Metastatic Breast Cancer.\n\nLinked to the drug Trastuzumab duocarmazine because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT03262935","url":"https://clinicaltrials.gov/study/NCT03262935"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-duocarmazine","lapatinib","capecitabine","trastuzumab","vinorelbine","eribulin"],"companies":["byondis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03262935","phase":"3","setting":"A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer","sponsor":"Byondis B.V.","started":"2017-12-15","startedType":"actual","yearReported":2023,"enrolled":437,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival","primary":true,"unit":"months","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":291,"value":7,"note":"95% CI 5.4 to 7.2; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":146,"value":4.9,"note":"95% CI 4.0 to 5.5"}],"hr":0.6401,"ci":[0.4885,0.8389],"p":"0.002","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"},{"endpoint":"Overall Survival","unit":"months","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":291,"value":21,"note":"95% CI 18.1 to 25.0; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":146,"value":19.5,"note":"95% CI 14.2 to 23.1"}],"hr":0.868,"ci":[0.676,1.1145],"p":"0.236","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"},{"endpoint":"Objective Response Rate","unit":"%","arms":[{"name":"(Vic-)Trastuzumab Duocarmazine","n":252,"value":27.8,"note":"95% CI 22.3 to 33.7; Figures from the ClinicalTrials.gov results section (first posted 2023-10-19), not from a publication"},{"name":"Physician's Choice","n":122,"value":29.5,"note":"95% CI 21.6 to 38.4"}],"p":"0.732","source":"https://clinicaltrials.gov/study/NCT03262935?tab=results"}]},"route":"/trials/nct03262935/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"eribulin","kind":"drug","name":"Eribulin","route":"/drugs/eribulin/"},{"id":"lapatinib","kind":"drug","name":"Lapatinib","route":"/drugs/lapatinib/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"trastuzumab-duocarmazine","kind":"drug","name":"Trastuzumab duocarmazine","route":"/drugs/trastuzumab-duocarmazine/"},{"id":"vinorelbine","kind":"drug","name":"Vinorelbine","route":"/drugs/vinorelbine/"}],"company":[{"id":"byondis","kind":"company","name":"Byondis","route":"/companies/byondis/"}]}}