EndoPredict
Research type
Research Study
Full title
The use of a prognostic tool (EndoPredict®) to inform adjuvant chemotherapy decision in low to medium risk Oestrogen Receptor Positive, Her-2 Negative Early Breast cancer: Feasibility, Acceptability and Economic impact in Multicentre UK NHS Practice.
IRAS ID
171171
Contact name
David Bloomfield
Contact email
Sponsor organisation
Brighton and Sussex University Hospital NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Breast cancer is common and causes a large burden of suffering. The majority of women with breast cancer are ER positive, HER-2 negative. Currently, a number of factors are used to stratify patients as being either high risk or low risk for distant metastases developing within 10 years of surgery. If patients fall within the low-risk group, they are treated with endocrine therapy and if they are high-risk, they are treated with endocrine therapy and chemotherapy. Patients who fall into the intermediate risk category present a challenge to clinicians and in many cases where there is uncertainty, chemotherapy may be used as a precautionary measure, resulting in possible over-use of chemotherapy in patients. Chemotherapy has a significant side effect profile and it is both resource-intensive and high cost.
EndoPredict is a multigene test for predicting likelihood of distant metastases in patients with ER-postive, HER-2 negative breast cancer. The tool combines gene expression and tumour prognotstic indicators to identify a subgroup of women who have low risk of distant recurrence of disease. This information can therefore help clinicians identify women who would not benefit from chemotherapy and save them the unnecessary side effects of treatment.
This trial will take place in high patient volume NHS breast oncology clinics in South-East England. The study will look at the impact of the EndoPredict tool on clinical decision-making by doctors, by comparing chemotherapy decisions before and after information from the EndoPredict is added. It also aims to explore patient attitudes surrounding risk and satisfaction when it is used. Cost- analysis will be performed to assess if there is longer-term financial benefit with its use.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0090
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion