EPHOS-B Version 1.0, 8 July 2009
Research type
Research Study
Full title
Effect of Perioperative AntiHER2 Therapy on Early Breast Cancer Study - Biological Phase
IRAS ID
6930
Contact name
Sarah Miller
Contact email
Sponsor organisation
University of Manchester
Eudract number
2008-005466-30
ISRCTN Number
15004993
Research summary
Research Summary
Around 20%-25% of women with breast cancer have cancers which contain high levels of the HER2 (Human Epidermal growth factor Receptor 2) protein which causes them to grow more quickly and recur earlier. Treatments directed against this protein improves survival. Currently treatments directed at the HER2 protein are given after surgery, but experimental evidence suggests that treatment given before surgery (i.e. preoperative) may further reduce the risk of secondary spread of the cancer to other parts of the body (metastasis). Patients often have a 6 week delay between diagnosis and starting chemotherapy and a 12 months delay before starting anti HER2 treatment. Earlier perioperative treatment for up to 4 weeks means that the drug will be present at the time when cells may survive and spread and this earlier treatment should prevent metastasis and improve the long term survival. The purpose of the EPHOS B study is to find out if treatment of HER2 positive breast cancer patients with anti HER2 therapy (trastuzumab or lapatinib) over the time of surgery inhibits cell growth (proliferation) or increases cell death (apoptosis) thus identifying whether either cell death or proliferation can be used as early indicators of response to the treatment. If evidence is found that either apoptosis or proliferation can be used as early indicators of response to the anti HER2 therapy, this would provide the basis for a subsequent larger phase 3 trial assessing the impact of perioperative HER2 therapy on cancer survival.
Summary of Results
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REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
09/H1208/52
Date of REC Opinion
12 Jan 2010
REC opinion
Further Information Favourable Opinion