EPHOS-B
Effect of perioperative anti-HER2 therapy on early breast cancer study – biological phase.
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: In follow up
Trial details
EPHOS-B is a phase III, multicentre, three group, randomised controlled trial to determine whether pre-operative treatment of HER2+ breast cancer patients with anti-HER2 therapy inhibits proliferation or increases apoptosis. Perioperative treatment consists of 11 days pre-operative treatment and further post-operative treatment.
Part 1 of EPHOS-B finished recruiting in August 2013. In this part of the study, 130 HER2+ patients received either:
- perioperative trastuzumab
- perioperative lapatinib
- standard care
Part 2 immediately superseded part 1, in response to new evidence supporting treatment with a combination of both trastuzumab and lapatinib. The next 127 in EPHOB-B patients recevied either:
- perioperative trastuzumab
- a combination of perioperative lapatinib and trastuzumab
- standard care
Part 2 of EPHOS-B closed to recruitment in September 2015. All EPHOB-B patients will be followed up for 10 years.
Results
EPHOS-B results were first presented at the European Breast Cancer Conference in March 2016.
In the combination group, some patients had a dramatic response in their tumours. In about one quarter of cases, patients had either no invasive tumour left by at surgery or only a very small amount of invasive tumour left.
The following articles explore these findings and discuss the next steps:
Further information for potential participants
Patient Information Sheet (Non Biological Centres)
Patient Information Sheet (Path A)
Patient Information Sheet (Path B)
Further information for healthcare professionals
Protocol
Further information
Chief Investigator: Professor Nigel Bundred, University of Manchester/University Hospital of South Manchester NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
ISRCTN: 15004993
Sponsors: The Institute of Cancer Research and University of Manchester/University Hospital of South Manchester NHS Foundation Trust
Funding: Cancer Research UK (CRUK/08/002) and GlaxoSmithKline
View EPHOS-B on the National Institute for Health Research website: NIHR - Be Part Of Research
A plain English summary is available from Cancer Research UK.
Publications and presentations
Bundred N, Cameron D, Armstrong A, Brunt AM, Cramer A, Dodwell D, Evans A, Hanby A, Hartup S, Hong A., Horgan K, Khattak I, Morden J, Naik J, Narayanan S, Ooi J, Shaaban A, Smith R, Webster-Smith M, Bliss J; on behalf of the EPHOS-B investigators. Effects of perioperative lapatinib and trastuzumab alone in combination in early HER2+ breast cancer - results from the EPHOS-B trial (CRUK/08/002). Eur J Cancer Supplements. 2016; 57 (Suppl 2): S5 #6LBA.
Bliss JM, Robison LE, Webster-Smith MF, Emson MA, Kilburn LS, Smith IE, Robertson J, Dowsett M, Bundred NJ, Cameron DA, Vidya R, Horgan K, Evans AA, Kokan JS, Pinhel I, A'Hern R; on behalf of the POETIC and EPHOS-B Trialists. A trial model for the future in the search for personalised medicine – the UK POETIC and EPHOS-B perioperative trials experience. Cancer Res. 2011; 71(24 Suppl): Abstract number OT2-03-04.