Authors' objectives: advanced or metastatic HER2-positive breast cancer. If licensed it would offer an additional oral treatment option for patients with this disease who have already received at least two prior HER2-directed therapies. Neratinib is a potent irreversible pan-erythroblastic leukaemia viral oncogene homolog (erbB) tyrosine kinase inhibitor that blocks signal transduction through three epidermal growth factor receptors, erbB1, erbB2/HER2, and erbB4, resulting in sustained inhibition of these growth-promoting pathways. Neratinib does not currently have Marketing Authorisation in the EU for any indication. Breast cancer is the most common cancer in the UK, accounting for 30% of all cancers in women. In England, there were 42,773 recorded cases of breast cancer in 2012 with an incidence of 130 per 100,000 population in women. An estimated 5% of patients present with metastatic breast cancer, and approximately 30% of people who present with localised breast cancer later develop metastatic disease. An estimated 20% of women with breast cancer will have HER2-positive tumours which are associated with a worse prognosis than HER2-negative tumours of similar stage and grade. The aim of treatment for advanced or metastatic breast cancer is to control disease-related symptoms, slow disease progression, minimise treatment-related toxicity, and reduce the intrusion of the disease and treatment on a patient's life. Treatment options for metastatic breast cancer may include: surgery (lumpectomy or mastectomy), radiotherapy, biological therapy (adjuvant or neoadjuvant trastuzumab), chemotherapy (adjuvant or neoadjuvant), and hormone therapy (adjuvant and neoadjuvant), as well as bisphosphonates for the management of treatment-induced bone loss. Neratinib, in combination with capecitabine, is currently in one phase III clinical trial comparing its effect on progression free survival against treatment with lapatinib in combination with capecitabine. The trial is expected to complete in May 2017.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/neratinib-with-capecitabine-for-advanced-or-metastatic-her2-positive-breast-cancer-third-line/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Centre (NIHR HSC)