{"entity":{"id":"nct04957212","kind":"trial","name":"P013 (CinnaGen pertuzumab) against Perjeta before surgery for HER2-positive breast cancer","aka":["P013 phase 3","IRCT20150303021315N11"],"tldr":"An Iranian phase 3 trial in which a locally made copy of pertuzumab gave the same rate of complete tumour disappearance before surgery as the original.","summary":"CinnaGen randomised 214 chemotherapy-naive women with operable, locally advanced or inflammatory HER2-positive breast cancer 1:1 to six three-weekly cycles of its pertuzumab P013 or Roche's Perjeta, each with trastuzumab, carboplatin and docetaxel. ClinicalTrials.gov lists 44 sites, all in Iran; the trial was registered first in the Iranian Registry of Clinical Trials (IRCT20150303021315N11, 11 June 2018) and later on ClinicalTrials.gov (12 July 2021), and ran from August 2018 to May 2020.\n\nIn the 2022 BMC Cancer report, breast pathological complete response in the per-protocol population was 67.62% with P013 and 71.57% with the reference product, a mean difference of -0.04 (95% CI -0.16 to 0.09), within the equivalence margin; secondary endpoints and safety were comparable. A correction to the paper was published the same year.","status":"completed","asOf":"2026-11-04","links":[{"label":"ClinicalTrials.gov NCT04957212","url":"https://clinicaltrials.gov/study/NCT04957212"},{"label":"Allahyari et al., BMC Cancer 2022","url":"https://doi.org/10.1186/s12885-022-09895-5"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/36071409/"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["biosimilar-manufacturing"],"targets":["her2"],"drugs":["pertuzumab","trastuzumab"],"companies":["cinnagen"],"institutions":[],"pathways":[],"terms":["biosimilar"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-p013-pertuzumab-biosimilar-bmc-cancer-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04957212","phase":"3","design":"equivalence","setting":"Phase 3, randomised, triple-blind equivalence trial of a proposed pertuzumab biosimilar against the originator with trastuzumab, carboplatin and docetaxel before surgery for HER2-positive breast cancer","sponsor":"CinnaGen","result":"Equivalent: breast pathological complete response 67.62% against 71.57% (BMC Cancer 2022).","started":"2018-08-11","startedType":"actual","yearReported":2022,"enrolled":214,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04957212/","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":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"cinnagen","kind":"company","name":"CinnaGen","route":"/companies/cinnagen/"}],"term":[{"id":"biosimilar","kind":"term","name":"Biosimilar","route":"/terms/biosimilar/"}],"paper":[{"id":"paper-p013-pertuzumab-biosimilar-bmc-cancer-2022","kind":"paper","name":"Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial","route":"/key-papers/paper-p013-pertuzumab-biosimilar-bmc-cancer-2022/"}]}}