{"entity":{"id":"nct06021379","kind":"trial","name":"AryoTrust (AryoGen trastuzumab) post-marketing safety study in HER2-positive breast cancer","aka":["TRA.ARY.FH.95.IV"],"tldr":"A safety study of a locally made copy of trastuzumab in 597 Iranian women treated after breast cancer surgery, whose authors judged it generally well tolerated.","summary":"AryoGen Pharmed followed women with HER2-positive non-metastatic breast cancer who received its trastuzumab, AryoTrust, every three weeks for nine cycles after adjuvant chemotherapy, at 15 Iranian sites listed on ClinicalTrials.gov, from February 2017 to August 2022. The 2024 report in Expert Opinion on Drug Safety covers 597 women and 5,313 injection cycles: 139 had at least one adverse event, the commonest being decreased ejection fraction (5.7%), peripheral neuropathy (5.36%) and nausea (5.19%); meningioma was the only life-threatening serious event and the mean ejection fraction did not change notably.","status":"completed","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT06021379","url":"https://clinicaltrials.gov/study/NCT06021379"},{"label":"Zahedi et al., Expert Opin Drug Saf 2024","url":"https://doi.org/10.1080/14740338.2024.2385483"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39076099/"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["biosimilar-manufacturing"],"targets":["her2"],"drugs":["trastuzumab"],"companies":["aryogen-pharmed"],"institutions":[],"pathways":[],"terms":["biosimilar"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-aryotrust-trastuzumab-pms-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06021379","phase":"observational","setting":"Post-marketing surveillance of a trastuzumab biosimilar in Iranian women with HER2-positive non-metastatic breast cancer after adjuvant chemotherapy","sponsor":"AryoGen Pharmed Co.","result":"Judged generally well tolerated by its authors in 597 women; decreased ejection fraction in 5.7% (Expert Opin Drug Saf 2024).","started":"2017-02-22","startedType":"actual","yearReported":2024,"enrolled":597,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06021379/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"technology":[{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"aryogen-pharmed","kind":"company","name":"AryoGen Pharmed","route":"/companies/aryogen-pharmed/"}],"term":[{"id":"biosimilar","kind":"term","name":"Biosimilar","route":"/terms/biosimilar/"}],"paper":[{"id":"paper-aryotrust-trastuzumab-pms-2024","kind":"paper","name":"Safety evaluation of the trastuzumab biosimilar in Iranian women with HER2-positive breast cancer undergoing adjuvant chemotherapy: a post-marketing surveillance","route":"/key-papers/paper-aryotrust-trastuzumab-pms-2024/"}]}}