NOSTRA-Feasibility Study, Version 1.0, 30 July 2018
Research type
Research Study
Full title
NOSTRA-Feasibility Study: 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-guided tumour bed core biopsies
IRAS ID
211232
Contact name
Daniel Rea
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Approximately 15% of early breast cancer patients in the UK have HER2-positive tumours. Within the neoadjuvant population HER2-positive cases split roughly 50:50 between ER-positive and ER-negative disease; thus an estimated 6-7.5% of all operable breast cancer patients have tumours with the HER2-positive, ER-negative phenotype. In the UK, this is approximately 3500 patients per year. At least half of these patients would be candidates for a dual-targeted therapy (a combination of neoadjuvant chemotherapy plus two anti-HER2 therapies), which results in consistently high pathalogical Complete Response (pCR) rates in the region of 70-80%, which are linked to good outcome. Patients with operable early stage breast cancer treated with neoadjuvant treatment always undergo surgery, regardless of their response to treatment. These patients are thus an appropriate group in which to initially explore omitting surgery.
The NOSTRA-Feasibility study is designed as a prerequisite to the conduct of a randomised phase III study which will 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 trial’s expert pathologists. 150 patients with early breast cancer will enter the study from hospitals around the UK to one of the three National Institute of Clinical Excellence (NICE) approved treatment regimens involving neoadjuvant chemotherapy plus dual-targeted anti-HER2 treatment.
The study encompasses an important translational research component, which involves the collection of diagnostic biopsies, tumour bed core biopsies and surgical excision specimens (including axilla biopsy specimen and SLNB specimen). Also incorporated into the study is collection of blood samples for the optional ctDNA substudy.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0275
Date of REC Opinion
17 Sep 2018
REC opinion
Favourable Opinion