Confirmation of pathological complete response (pCR) pre-operatively
Research type
Research Study
Full title
Confirmation of pathological complete response (pCR) pre-operatively by U/S guided core biopsy in cases of radiological complete response (rCR) on MRI following Neo-Adjuvant Chemotherapy (NAC) of breast cancer.
IRAS ID
189848
Contact name
Manjo Doug
Contact email
Sponsor organisation
Hinchingbrooke Health Care NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Almost 30% of patients with breast cancer undergo chemotherapy before surgery. Patients have MRI scans throughout treatment (base line, mid, final) to assess their response to the chemotherapy. Nearly 20-25% will show complete response on final MRI. This result is compared the the histopathology (laboratory analysis) of the tumour following surgery. In only 50-60% of cases do these two results correlate.
In this study we aim to perform an additional ultrasound guided biopsy of the tumour bed area in patients who show complete response to chemotherapy treatment on final MRI. This biopsy will be used to assess whether true complete responders can be correctly identified by biopsy before surgery. Patients in the study will still undergo surgery as per current practice and the post-surgery histopathology results will be compared to the pre-operative biopsy results. Matching results will show that the pre-operative biopsy is accurate in confirming complete response.
If complete response can be accurately confirmed pre-operatively; this will open the door for a randomised control trial that the patients who achieve true complete response can be candidates for undergoing radiotherapy alone without the need for invasive surgery.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/0202
Date of REC Opinion
15 Mar 2016
REC opinion
Unfavourable Opinion