{"entity":{"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","aka":[],"tldr":"In 597 Iranian women given a locally made copy of trastuzumab after breast cancer surgery, the commonest side effects were reduced heart pumping function, nerve damage and nausea, and the authors judged it generally well tolerated.","summary":"Post-marketing surveillance of AryoTrust, the trastuzumab made by AryoGen in Iran, in women with HER2-positive non-metastatic breast cancer who had had adjuvant chemotherapy and then received trastuzumab every three weeks for nine cycles, from February 2017 to August 2022 (NCT06021379). Safety data were collected in booklets.","asOf":"2026-11-04","links":[{"label":"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":[],"targets":["her2"],"drugs":["trastuzumab"],"companies":["aryogen-pharmed"],"institutions":[],"pathways":[],"terms":["biosimilar"],"trials":["nct06021379"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Expert Opinion on Drug Safety","year":2024,"doi":"10.1080/14740338.2024.2385483","pmid":"39076099","authors":"Zahedi F, Jafari A, Nasiri Motlagh B, et al.","paperType":"real-world","findings":["597 women (mean age 48.13) received 5,313 injection cycles; 139 had at least one adverse event.","The commonest were decreased ejection fraction (5.7%), peripheral neuropathy (5.36%) and nausea (5.19%); meningioma was the only life-threatening serious event.","Mean ejection fraction did not change notably during the study."],"whatItMeans":"Routine-use safety data for a trastuzumab made in Iran, collected at 15 sites in ten cities across the country.","caveats":["No comparison group; industry-sponsored.","Each woman was followed for nine three-weekly cycles of trastuzumab, so events after that window are not captured."],"participants":597},"route":"/key-papers/paper-aryotrust-trastuzumab-pms-2024/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"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/"}],"trial":[{"id":"nct06021379","kind":"trial","name":"AryoTrust (AryoGen trastuzumab) post-marketing safety study in HER2-positive breast cancer","route":"/trials/nct06021379/"}]}}