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Brief Title: NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer
Official Title: Can Patients With Residual Cancer After Chemotherapy for Early Breast Cancer be Identified With Multiple Ultrasound-guided Biopsies?
Study ID: NCT04118192
Brief Summary: A prospective non-randomised multi-centre feasibility study to assess if patients with residual cancer following dual-targeted neoadjuvant chemotherapy treatment for HER2-positive, ER-negative early breast cancer can be identified by multiple ultrasound (US)-guided tumour bed core biopsies
Detailed Description: The NOSTRA-Feasibility study is designed to determine if it is safe to omit surgery after the planned neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment. The study is needed to determine whether patients with residual cancer can be identified by histological examination of multiple ultrasound-guided tumour bed core biopsies following dual-targeted neoadjuvant treatment for HER2-positive, ER-negative early primary breast cancer and whether there is concordance between local pathology reporting and central pathology reporting by the trials expert pathologists.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Basildon Hospital, Basildon, Essex, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
City Hospital, Birmingham, , United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Blackpool Teaching Hospitals NHS Trust, Blackpool, , United Kingdom
Southmead Hospital, Bristol, , United Kingdom
University Hospital of Llandough, Cardiff, , United Kingdom
Cheltenham General Hospital, Cheltenham, , United Kingdom
Dumfries and Galloway Royal Infirmary, Dumfries, , United Kingdom
Western General, Edinburgh, , United Kingdom
Northwick Park Hospital, Harrow, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
Royal Liverpool Hospital, Liverpool, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Borders General Hospital, Melrose, , United Kingdom
Royal Victoria Infirmary, Newcastle Upon Tyne, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Peterborough City Hospital, Peterborough, , United Kingdom
Poole Hospital, Poole, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom
Arrowe Park Hospital, Upton, , United Kingdom
Thomas Linacre Centre, Wigan, , United Kingdom
Name: Daniel Rea
Affiliation: University of Birmingham
Role: PRINCIPAL_INVESTIGATOR