biostudies-literatureEarl HMCancer Research UKNational Institute for Health Research (NIHR)National Institute of Health Research Health Technology Assessment Programme2599-2612https://www.ebi.ac.uk/biostudies/studies/S-EPMC6615016biostudies-literatureUnknown393(10191)<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 evLancet (London, England)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.PMC66150169675NF-SI-0611-1015418832NF-SI-0515-1009006/303/98Shah NDaly MJegannathen ATaylor WWright KInnes HNelmes DMiles DMcAdam KBloomfield DHiggins HBArmstrong ABale CBedi CRaja FSimmonds PHumphreys ADown SHayward LHowe DDhadda AMukesh MAbraham JEBenstead KStorey NMansi JNeal ARigg ANeville-Webbe HAh-See MLHall PSMcGolick TLee DWoodings PEaton DKelleher MMahler-Araujo BThanvi NHiller LBarthakur UTipples KHarries MSims EEichholz AEarl HMEpurescu DHarnett ANRoe HPERSEPHONE Steering Committee and Trial InvestigatorsCaldas CCliff JBarraclough LReed CNewby JVarughese MBradley CGoodman AChhabra APlummer CProvenzano EKristeleit HAgarwal RWalji NDunn JAArcher CHughes-Davies LHulme CPersic MGoh CVaidya JRea DVinayan AMacGregor CChurn MVallier ALSimcock RO'Reilly SDe Silva-Minor SDin OCrellin PGounaris ILoi SBowen RMcCabe CMithal NHarper-Wynne CEarl HPettit LWilcox MMehra RRaj SCleator SHadaki MMarshall JWardley AMOstler PGrieve RButt MRaynes KAllerton RCameron DAMoss CMoss ASmith SAlgurafi HJafri MWaters SBrown JLupton SYahya SMalik Zfalse6 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.<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 ev2019-01-01T00:00:00Z2019 Jun2026-05-07T02:15:43.67Z2019-07-30T07:03:02ZS-EPMC66150163117815210.1016/S0140-6736(19)30650-6