Developing a diagnostic tool to predict response to chemotherapy v1.0
Research type
Research Study
Full title
Developing a diagnostic tool, using SPAG5, for predicting clinical benefit from standard anthracycline combination (AC) chemotherapy in breast cancer
IRAS ID
266220
Contact name
Stephen Y.T. Chan
Contact email
Sponsor organisation
Nottingham University Hospitals, NUH, NHS Trust
Clinicaltrials.gov Identifier
II-LA-0417-20004, NIHR i4i Project; 2125/N0172, NUH Charity, SPAG5 Diagnostic Project
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Every year nearly 62,000 people are diagnosed with breast cancer in the UK. One in eight women in the UK will develop breast cancer in their lifetime.
We are developing an inexpensive test to accurately predict how breast cancer patients will respond to the standard chemotherapy Anthracycline (AC). Only 15-20% of patients have no tumour remaining following AC, so a method of treatment selection is urgently needed.
Breast cancers are currently treated with a combination of chemotherapy, targeted therapy and surgery. However, breast cancers are not identical; each tumour’s individual characteristics affect how they respond to treatment. We recently discovered a new tumour characteristic, a protein which is unusually active in approximately 20% of breast cancers. We found that a patient whose tumour showed high activity often respond well to AC, and vice versa.
AC is an aggressive treatment which can potentially cause severe side effects, including a risk of permanent heart damage. It is important, therefore, to spare those patients who will not benefit from AC the physical and emotional side-effects of this drug. Currently, there is no predictive test for selecting which patients will benefit from AC and which will not. We have shown that we can accurately make this prediction by testing the activity of a protein called ‘SPerm associated AntiGen 5’ (SPAG5) in tumour tissue.
We aim to develop a clinical SPAG5 testing kit that can be used by hospital laboratories to determine the activity of SPAG5 in the tumour. This information will help guide the choice of treatment and achieve better patient outcomes.
In June 2018 we started a three year NIHR funded project to develop a lab test that could form the basis of a SPAG5 testing kit.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0301
Date of REC Opinion
4 Oct 2019
REC opinion
Favourable Opinion