NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer
NCT ID: NCT04118192
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
72 participants
OBSERVATIONAL
2019-05-22
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Tumour bed core biopsy
Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment
Eligibility Criteria
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Inclusion Criteria
* Tumour size ≥ 1cm and visible on US (T1c to T4d)
* Patient fit and willing to receive, or is already receiving and has received no more than five cycles of a NOSTRA-Feasibility Study approved treatment regimen, in the opinion of the responsible clinician
* Eastern Co-operative Group (ECOG) performance status of 0 or 1
* Women of child-bearing potential, prepared to adopt highly effective contraceptive measures if sexually active for at least 6 months after completion of study medication
* Female, 18 years or older
* Able to provide informed consent for the study
* Availability of embedded paraffin tumour blocks from pre-chemotherapy biopsy
* The radiology team are able and willing to perform the tumour bed core biopsies
* Patient has not yet started neoadjuvant treatment
* Patient is willing and able to give blood samples as per ctDNA Sub-Study Guidelines
Exclusion Criteria
* Unequivocal evidence of distant metastatic disease at registration
* Multi-focal disease at diagnosis
* Active malignancy
* Previous chemotherapy
* Prior extensive radiotherapy (as judged by the Investigator) to bone marrow
* Risk factors precluding the safe administration of the intended cytotoxic chemotherapy regimen
* Patient unsuitable for the planned dual-targeted anti-HER2 treatment in opinion of the Investigator
* Prior diagnosis of cardiac failure
* Uncontrolled hypertension, coronary heart disease or other significant cardiac abnormality
* Bleeding diathesis
* Any evidence of other disease which in the opinion of the Investigator places the patient at high risk of treatment related complications
* Pregnant (female patients of child bearing potential must have a urine or blood Human Chorionic Gonadotropin test performed to rule out pregnancy prior to study entry)
* Patient lactating
* Patients who have received live vaccine within 4 weeks of the date of study entry
* Any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up
* Patient unfit and/or unwilling to undergo surgery
* Patient unwilling or unable to comply with scheduled visits, treatment plan and study procedures
* Patient has started protocol non-compliant neo-adjuvant chemotherapy
* Patient has started approved neoadjuvant chemotherapy but insufficient data is available to complete relevant CRFs
* Patient has already received more than five cycles of approved neoadjuvant chemotherapy
18 Years
FEMALE
No
Sponsors
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Roche Pharma AG
INDUSTRY
Cancer Research UK
OTHER
University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Daniel Rea
Role: PRINCIPAL_INVESTIGATOR
University of Birmingham
Locations
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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
Countries
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Other Identifiers
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RG_16-108
Identifier Type: -
Identifier Source: org_study_id
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