PEAR-TNBC
Research type
Research Study
Full title
Prospective Evaluation of image-based Artificial intelligence Research and development tool for precision neoadjuvant Triple-Negative Breast Cancer treatment (PEAR-TNBC)
IRAS ID
295589
Contact name
Peter Hall
Contact email
Sponsor organisation
Ourotech Limited (trading as Pear Bio)
Duration of Study in the UK
1 years, 10 months, 15 days
Research summary
Triple negative breast cancer (TNBC) is a subtype of breast cancer that is associated with a worse survival than other types of breast cancer. Patients whose TNBC has not spread to distant sites in the body (non-metastatic) are usually treated with chemotherapy followed by surgery. If there is no sign of the cancer remaining in any of the specimens removed at surgery, called a pathological complete response (pCR), then the outcomes are significantly better than if any cancer remains (non-pCR), with the risk of recurrence and death being reduced by around 75-80%. Using current chemotherapy combinations, the pCR rate in patients with TNBC is only around 40%. There is no test presently to determine the optimal combination of chemotherapy drugs to achieve a pCR for an individual patient’s TNBC.
Pear Bio have developed a novel test that uses a small sample from a patient’s cancer and analyses its response to different chemotherapy combinations simultaneously in the laboratory in order to predict the likelihood of a particular combination achieving a pCR. The test was initially developed using samples that had already been collected (retrospective study) and the aim now is to test its accuracy in a prospective study.This is an observational study for patients with newly diagnosed non-metastatic TNBC who are planned to receive chemotherapy followed by surgery. Up to 30 patients will undergo an additional biopsy and then proceed with chemotherapy as determined by their oncologist followed by surgery. The response of the biopsy sample to the same chemotherapy combination, as well as others, will be analysed using the Pear Bio test. For this study, the treating oncologist will not be told of the test outcome. This will then be compared to the outcome at surgery (pCR versus non-pCR) in order to determine the accuracy of the test.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/PR/1027
Date of REC Opinion
28 Oct 2021
REC opinion
Further Information Favourable Opinion