{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Earl HM"],"funding":["Cancer Research UK","National Institute for Health Research (NIHR)","National Institute of Health Research Health Technology Assessment Programme"],"pagination":["2599-2612"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC6615016"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["393(10191)"],"pubmed_abstract":["<h4>Background</h4>Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is non-inferior to the standard 12-month treatment regarding disease-free survival.<h4>Methods</h4>This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered ev"],"journal":["Lancet (London, England)"],"pubmed_title":["6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial."],"pmcid":["PMC6615016"],"funding_grant_id":["9675","NF-SI-0611-10154","18832","NF-SI-0515-10090","06/303/98"],"pubmed_authors":["Shah N","Daly M","Jegannathen A","Taylor W","Wright K","Innes H","Nelmes D","Miles D","McAdam K","Bloomfield D","Higgins HB","Armstrong A","Bale C","Bedi C","Raja F","Simmonds P","Humphreys A","Down S","Hayward L","Howe D","Dhadda A","Mukesh M","Abraham JE","Benstead K","Storey N","Mansi J","Neal A","Rigg A","Neville-Webbe H","Ah-See ML","Hall PS","McGolick T","Lee D","Woodings P","Eaton D","Kelleher M","Mahler-Araujo B","Thanvi N","Hiller L","Barthakur U","Tipples K","Harries M","Sims E","Eichholz A","Earl HM","Epurescu D","Harnett AN","Roe H","PERSEPHONE Steering Committee and Trial Investigators","Caldas C","Cliff J","Barraclough L","Reed C","Newby J","Varughese M","Bradley C","Goodman A","Chhabra A","Plummer C","Provenzano E","Kristeleit H","Agarwal R","Walji N","Dunn JA","Archer C","Hughes-Davies L","Hulme C","Persic M","Goh C","Vaidya J","Rea D","Vinayan A","MacGregor C","Churn M","Vallier AL","Simcock R","O'Reilly S","De Silva-Minor S","Din O","Crellin P","Gounaris I","Loi S","Bowen R","McCabe C","Mithal N","Harper-Wynne C","Earl H","Pettit L","Wilcox M","Mehra R","Raj S","Cleator S","Hadaki M","Marshall J","Wardley AM","Ostler P","Grieve R","Butt M","Raynes K","Allerton R","Cameron DA","Moss C","Moss A","Smith S","Algurafi H","Jafri M","Waters S","Brown J","Lupton S","Yahya S","Malik Z"],"additional_accession":[]},"is_claimable":false,"name":"6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial.","description":"<h4>Background</h4>Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is non-inferior to the standard 12-month treatment regarding disease-free survival.<h4>Methods</h4>This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered ev","dates":{"release":"2019-01-01T00:00:00Z","publication":"2019 Jun","modification":"2026-05-07T02:15:43.67Z","creation":"2019-07-30T07:03:02Z"},"accession":"S-EPMC6615016","cross_references":{"pubmed":["31178152"],"doi":["10.1016/S0140-6736(19)30650-6"]}}