The Use of a prognostic tool (EndoPredict®) to inform adjuvant chemotherapy decisions in low to medium risk Oestrogen Receptor Positive, Her-2 Negative Early Breast cancer: Feasibility, Acceptability and Economic impact in Multicentre UK NHS Practice
Trial acronym: EndoPredict
Description
Early breast cancer is unfortunately common, and causes a large burden of suffering. The majority of women with breast cancer are ER positive, and many node negative. The major adjuvant systemic intervention here is anti-hormonal therapy. However chemotherapy needs to be considered on an individual basis, and this causes patients and their clinician’s great therapeutic uncertainty. It is understandable that given the potential for death from metastatic breast cancer, patients and clinicians will consider every additional therapeutic option with a resultant potential overtreatment with systemic chemotherapy (Gnant 2009). Systemic chemotherapy is associated with side effects, which can cause unpleasant physical symptoms and affect family, social and work relationships and roles. Chemotherapy is resource intensive with the use of high cost drugs and the need for specialised staff and facilities to deliver treatment. Demand for chemotherapy across all cancer sites is growing and the NHS system is under great strain.
EndoPredict is a multigene test for predicting the likelihood of distant recurrence in patients with ER-positive, HER2-negative breast cancer treated with adjuvant endocrine therapy only. An Austrian study suggests that Endopredict results can alter the decision for chemotherapy, made using clinical guidelines (Dubsky, Filipits et al. 2013).
Objectives of this study are to: To test the feasibility of using Endopredict in high patient volume, NHS breast oncology clinics in South-East England. To compare and contrast adjuvant chemotherapy decisions before and after additional information from Endopredict. To conduct an initial exploration into patient and clinician attitudes to risk and satisfaction with decision making using Endopredict. To perform a simple cost-minimisation analysis of the effect of change in use of chemotherapy – from the perspective of the oncology service. To perform a Cost-Utility analysis of the longer term impact of potentially improved treatment for early breast cancer.
Study design: The trial is a non-randomised application of a licensed medical technology test in the clinical setting.
Trial status: Complete
Chief Investigator: Dr David Bloomfield
Trial Manager: Jane Cox
Start date: 16 July 2015
End date: 27 October 2016
Recruitment target: 151
Summary of study results: n/a
For further information contact:
E: Jane.Cox@bsuh.nhs.uk