Authors' objectives: Trastuzumab is a humanised monoclonal antibody treatment that works to prolong life and save the lives of women with breast cancers that carry the Her-2 receptor on the surface of their tumours. Trastuzumab reacts with this cell surface receptor, and blocks its normal action which is to make the cells divide and the cancer grow. Trials reported in 2005/6, show very considerable improvements in outcomes - preventing breast cancer coming back and spreading, in patients who were treated with trastuzumab as well as chemotherapy, when compared with those who simply received chemotherapy. A Finnish study showed that when trastuzumab was given at the same time as chemotherapy, only 9 weeks treatment could produce similar results. This latter study was small, and needs to be repeated. In the study presented here we plan to invite 4200 women with Her-2 positive breast cancer to take part, and to be allocated to either standard treatment - 12 months of trastuzumab, or to 6 months of trastuzumab. This 'study arm' of treatment allocation, would have a total treatment time of 6 months shorter than the equivalent 'standard' arm. We have set up an International Collaboration with the French Institut of Cancer (INCa) which has a study which is very similar. Entering 4000 patients into PERSEPHONE will allow us to definitively answer the question - 'Is 6 months trastuzumab treatment sufficient?' If it is enough this has very important implications for all Her 2 positive breast cancer patients, and for the costs of providing such treatment. Trastuzumab is defined as a targetted, anti-cancer therapy which is a 'biological' and not a chemotherapy. Many other similar such treatments are in development. Unless the question of duration of adjuvant treatment is answered, all these new treaments will be introduced for a 12 month duration. The study will carefully check all aspects of treatment, and also outcomes (survival and absence of cancer coming back) to make quite certain that patients who receive less treatment (6m), are not being disadvantaged. We are confident that this will not be the case, because of the exciting results of the Finnish study, but testing this properly within a clinical study is essential. The collaborative team for this project have track records individually in all aspects of the proposed research and its organisation; development, running, and analysis.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/0630398/#/

Year Published: 2020

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/hta24400#/abstract

Requestor: NIHR Health Technology Assessment programme

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: https://doi.org/10.3310/hta24400

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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