Six versus 12 months' adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT

Earl, Helena; Hiller, Louise; Vallier, Anne-Laure; Loi, Shrushma; McAdam, Karen; Hughes-Davies, Luke; Rea, Daniel; Howe, Donna; Raynes, Kerry; Higgins, Helen B; Wilcox, Maggie; Plummer, Chris; Mahler-Araujo, Betania; Provenzano, Elena; Chhabra, Anita; Gasson, Sophie; Balmer, Claire; Abraham, Jean E; Caldas, Carlos; Hall, Peter; Shinkins, Bethany; McCabe, Christopher; Hulme, Claire; Miles, David; Wardley, Andrew M; Cameron, David A; Dunn, Janet A

doi:10.3310/hta24400

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This trial showed that in patients with HER2-positive early breast cancer, 6 months' adjuvant trastuzumab was non-inferior to 12 months', with less cardiac toxicity and fewer severe adverse events.

Helena Earl , Louise Hiller , Anne-Laure Vallier , Shrushma Loi , Karen McAdam , Luke Hughes-Davies , Daniel Rea , Donna Howe , Kerry Raynes , Helen B Higgins , Maggie Wilcox , Chris Plummer , Betania Mahler-Araujo , Elena Provenzano , Anita Chhabra , Sophie Gasson , Claire Balmer , Jean E Abraham , Carlos Caldas , Peter Hall , Bethany Shinkins , Christopher McCabe , Claire Hulme , David Miles , Andrew M Wardley , David A Cameron & Janet A Dunn .

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Helena Earl ^1,^2,^3,^*, Louise Hiller ⁴, Anne-Laure Vallier ⁵, Shrushma Loi ⁴, Karen McAdam ^6,⁷, Luke Hughes-Davies ^1,⁷, Daniel Rea ⁸, Donna Howe ⁴, Kerry Raynes ⁴, Helen B Higgins ⁴, Maggie Wilcox ⁹, Chris Plummer ^10,¹¹, Betania Mahler-Araujo ^12,¹³, Elena Provenzano ^3,¹², Anita Chhabra ¹⁴, Sophie Gasson ⁴, Claire Balmer ⁴, Jean E Abraham ^1,^2,³, Carlos Caldas ^1,^2,^3,¹⁵, Peter Hall ¹⁶, Bethany Shinkins ¹⁷, Christopher McCabe ¹⁸, Claire Hulme ^17,¹⁹, David Miles ²⁰, Andrew M Wardley ^21,²², David A Cameron ¹⁶, Janet A Dunn ⁴

¹ Department of Oncology, University of Cambridge, Addenbrooke’s Hospital, Cambridge, UK
² Cambridge Breast Cancer Research Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
³ NIHR Cambridge Biomedical Research Centre, Cambridge, UK
⁴ Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
⁵ Cambridge Clinical Trials Unit – Cancer Theme, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
⁶ Department of Oncology, North West Anglia NHS Foundation Trust, Peterborough City Hospital, Peterborough, UK
⁷ Department of Oncology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
⁸ Cancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK
⁹ Independent Cancer Patients’ Voice, London, UK
¹⁰ Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK
¹¹ Department of Cardiology, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
¹² Department of Histopathology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
¹³ Metabolic Research Laboratories, University of Cambridge, Cambridge, UK
¹⁴ Pharmacy, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s Hospital, Cambridge, UK
¹⁵ Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK
¹⁶ Edinburgh University Cancer Research Centre, Institute of Genetics and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK
¹⁷ Academic Unit of Health Economics, University of Leeds, Leeds, UK
¹⁸ Institute of Health Economics, Edmonton, AB, Canada
¹⁹ Health Economics Group, University of Exeter Medical School, Exeter, UK
²⁰ Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK
²¹ NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
²² Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK
^* Corresponding author Email: hme22@cam.ac.uk

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