Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
NCT ID: NCT04109079
Last Updated: 2025-12-22
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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RECRUITING
NA
1900 participants
INTERVENTIONAL
2021-02-26
2030-02-28
Brief Summary
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Detailed Description
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Aim: To assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
Methods:
Study design: A pragmatic, phase 3, open, randomised, multicentre trial and embedded economic evaluation in which participants will be randomised in a 1:1 ratio.
Study population: T1-3N1M0 breast cancer patients aged 18 years or older, with needle biopsy proven nodal metastases, who after NACT have no residual cancer in the lymph nodes on dual tracer sentinel node biopsy and removal of at least 3 lymph nodes (sentinel nodes and marked involved node).
Intervention: All participants will receive human epidermal growth factor receptor 2 (HER2)-targeted treatment, endocrine therapy and radiotherapy to breast or chest wall, if indicated according to local guidelines. Patients in the intervention group will not receive further axillary treatment (ALND or ART), whereas those receiving standard care will receive axillary treatment (ALND or ART) as per local guidelines. Follow-up is annually for at least 5 years.
Outcomes: The co-primary outcomes are disease free survival(DFS) and self-reported lymphoedema defined as 'yes' to the two questions participants will be asked - 'arm heaviness during the past year' and 'arm swelling now' from the Lymphoedema and Breast Cancer Questionnaire at 5 years.
Secondary outcomes: arm function assessed by the QuickDASH (disabilities of the arm, shoulder and hand) questionnaire; health related quality of life assessed using euroqol EQ-5D-5L; axillary recurrence free interval (ARFI); local recurrence; regional (nodal) recurrence; distant metastasis; overall survival; contralateral breast cancer; non-breast malignancy; costs; quality adjusted life years (QALYs) and cost-effectiveness.
Sample size: A sample size of 1900 patients would have the ability to demonstrate a 3.5% non-inferiority margin with a 5% 1-sided significance level and 85% power, allowing for 7% non-collection of primary outcome data assuming a 90% 5-year disease free survival rate in the control arm. It would also be able to detect at least a 5% difference in proportion of patients with lymphoedema with 90% power, a 5% 2-sided significance level and allowing for 25% non-collection of primary outcome data over 5 years.
Analysis plan: All analyses will be carried out on an intention-to-treat basis to preserve randomisation, avoid bias from exclusions and preserve statistical power. Time to event outcomes, including disease free survival and axillary recurrence free interval, will be assessed using Kaplan-Meier curves and compared using Cox proportional hazards models. The proportion of patients experiencing lymphoedema at 5 years will be compared across trial arms using a chi-squared test and a logistic regression model used to adjust for stratification variables. Arm morbidity and health related quality of life will be scored using the appropriate manuals and assessed using a longitudinal mixed model regression analysis if model assumptions valid or a standardised area-under-the-curve analysis. For economic evaluation, incremental cost per QALY gained at 5 years will be estimated.
Timelines for delivery: Total project duration is 120 months based on 6 months for set up; 60 months recruitment period (including an 18 months internal pilot phase); and 54 months for follow up, analysis, writing up and dissemination.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No axillary treatment
Patients in this arm will not receive axillary treatment (axillary lymph node dissection or axillary radiotherapy). Supraclavicular fossa radiotherapy is not allowed when randomised to this arm.
Breast or chest wall radiotherapy
Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Axillary treatment
Patients in this arm will receive axillary treatment. Axillary treatment can be axillary lymph node dissection or axillary radiotherapy.
Axillary lymph node dissection
Participants will undergo removal of at least level I and II axillary lymph nodes.
Axillary radiotherapy
Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Breast or chest wall radiotherapy
Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Interventions
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Axillary lymph node dissection
Participants will undergo removal of at least level I and II axillary lymph nodes.
Axillary radiotherapy
Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Breast or chest wall radiotherapy
Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Eligibility Criteria
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Inclusion Criteria
* Patients with occult primary breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are also eligible for the study.
* Fine-needle aspiration (FNA) or core biopsy confirmed axillary nodal metastases at presentation
* Oestrogen receptor and HER2 status evaluated on primary tumour
* Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
* Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
* Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed in total (sentinel nodes and marked node).
* If a single tracer SNB is performed, the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
* If the node is not marked, or the marked node is not removed, the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
* If fewer than 3 nodes are found on histology, the patient is eligible only if BOTH points a) and b) below, are met:
1. involved node was marked and removed during SNB; and
2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed (including the marked node).
* No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)
* Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study.
Exclusion Criteria
* Sentinel node biopsy prior to NACT
* Previous axillary surgery on the same body side as the scheduled targeted sampling
* Any previous cancer within 5 years or concomitant malignancy except
* basal or squamous cell carcinoma of the skin
* in situ carcinoma of the cervix
* in situ melanoma
* contra- or ipsilateral in situ breast cancer
18 Years
ALL
No
Sponsors
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University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Dr Amit Goyal
Consultant Oncoplastic Breast Surgeon & Associate Professor
Principal Investigators
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Amit Goyal, MS, MD, FRCS
Role: PRINCIPAL_INVESTIGATOR
Royal Derby Hospital, Derby, UK
Locations
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St Vincent's University Hospital - St Vincent's Healthcare Group
Dublin, , Ireland
St Luke's Hospital - St Luke's Radiation Oncology Network
Dublin, , Ireland
Beaumont Hospital - Royal College of Surgeons in Ireland
Dublin, , Ireland
Galway University Hospitals - Saolta University Health Care Group
Galway, , Ireland
Airedale General Hospital - Airedale NHS Foundation Trust
Keighley, BD20 6TD, United Kingdom
Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
Carlisle, CA2 7HY, United Kingdom
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Camberley, GU16 7UJ, United Kingdom
Raigmore Hospital - NHS Highland
Inverness, IV2 3UJ, United Kingdom
James Paget Hospital -James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
Macclesfield District General Hospital - East Cheshire NHS Trust
Macclesfield, SK10 3BL., United Kingdom
Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust
Shrewsbury, SY3 8XQ, United Kingdom
Aberdeen Royal Infirmary - NHS Grampian
Aberdeen, , United Kingdom
Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford, , United Kingdom
Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne, , United Kingdom
University Hospital Crosshouse - NHS Ayrshire and Arran
Ayr, , United Kingdom
Basildon University Hospital - Mid and South Essex NHS Foundation Trust
Basildon, , United Kingdom
Belfast City Hospital - Belfast Health and Social Care Trust
Belfast, , United Kingdom
QEHB- University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
City Hospital -Sandwell and West Birmingham NHS Trust
Birmingham, , United Kingdom
Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , United Kingdom
Royal Bolton Hospital - Bolton NHS Foundation Trust
Bolton, , United Kingdom
St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, , United Kingdom
Southmead Hospital - North Bristol NHS Trust
Bristol, , United Kingdom
Burnley General Hospital- East Lancashire Hospitals NHS Trust
Burnley, , United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust
Cheltenham, , United Kingdom
Countess of Chester Hospital - Countess of Chester Hospital NHS Trust
Chester, , United Kingdom
Leighton Hospital - Mid Cheshire NHS Foundation Trust
Crewe, , United Kingdom
Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust
Darlington, , United Kingdom
Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust
Derby, , United Kingdom
Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, , United Kingdom
Russell's Hall Hospital - The Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway
Dumfries, , United Kingdom
Queen Margert Hospital - NHS Fife
Dunfermline, , United Kingdom
University Hospital Hairmyres - NHS Lanarkshire
East Kilbride, , United Kingdom
Western General Hospital -NHS Lothian
Edinburgh, , United Kingdom
Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust
Exeter, , United Kingdom
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
Gateshead, , United Kingdom
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, , United Kingdom
Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust
Guildford, , United Kingdom
Harrogate District Hospital - Harrogate and District NHS Foundation Trust
Harrogate, , United Kingdom
Hereford County Hospital- Wye Valley NHS Trust
Hereford, , United Kingdom
Wycombe Hospital - Buckinghamshire Healthcare NHS Trust
High Wycombe, , United Kingdom
Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, , United Kingdom
Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust
Ipswich, , United Kingdom
West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust
Isleworth, , United Kingdom
Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, , United Kingdom
Forth Valley Royal Hospital - NHS Forth Valley
Larbert, , United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Glenfield Hospital - University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust
Lincoln, , United Kingdom
Prince Phillip Hospital -Hywel Dda University Health Board
Llanelli, , United Kingdom
North Middlesex University Hospital - North Middlesex University Hospital NHS Trust
London, , United Kingdom
The Whittington Hospital - Whittington Health NHS Trust
London, , United Kingdom
UCL Hospital - University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Royal Free Hospital - Royal Free London NHS Foundation Trust
London, , United Kingdom
Kings College Hospital - King's College Hospital NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Charing Cross Hospital -Imperial College Healthcare NHS Trust
London, , United Kingdom
Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust
Luton, , United Kingdom
Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust
Manchester, , United Kingdom
North Manchester General -Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Borders General Hospital -NHS Borders
Melrose, , United Kingdom
Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
The James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough, , United Kingdom
Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust
Milton Keynes, , United Kingdom
Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust
North Shields, , United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Royal Alexandra Hospital - NHS Greater Glasgow and Clyde
Paisley, , United Kingdom
Derriford Hospital - University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust
Portsmouth, , United Kingdom
St Helen's Hospital - St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, , United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, , United Kingdom
East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust
Redhill, , United Kingdom
Rotherham General Hospital - The Rotherham NHS Foundation Trust
Rotherham, , United Kingdom
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
St Alban's Hospital - West Hertfordshire Hospitals NHS Trust
St Albans, , United Kingdom
Lister Hospital - East and North Hertfordshire NHS Foundation Trust
Stevenage, , United Kingdom
University Hospital North Tees - North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, , United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, , United Kingdom
Singleton hospital - Swansea Bay University Health Board
Swansea, , United Kingdom
Musgrove park Hospital -Somerset NHS Foundation Trust
Taunton, , United Kingdom
Croydon University Hospital - Croydon Health Services NHS Trust
Thornton Heath, , United Kingdom
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, , United Kingdom
Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust
Wakefield, , United Kingdom
Southend Hospital and Broomfield Hospital -Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, , United Kingdom
Royal Albert Edward Infirmary - Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, , United Kingdom
King Edward VII Hospital - Frimley Health NHS Foundation Trust
Windsor, , United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust
Worcester, , United Kingdom
Yeovil District Hospital -Yeovil District Hospital NHS Trust
Yeovil, , United Kingdom
York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust
York, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Michael Boland
Role: primary
John Armstrong
Role: primary
Aoife Lowery
Role: primary
Claire Murphy
Role: primary
Ludger Barthelmes
Role: primary
Kaiyumars Contractor
Role: primary
Hisham Osman
Role: backup
Eileen Anderson
Role: primary
Sue Down
Role: primary
Brendan Smith
Role: primary
Jalal Kokan
Role: primary
Laura Pettit
Role: primary
Beatrix Elsberger
Role: primary
Anneliese Lawn
Role: primary
Pardeep Arora
Role: primary
Graeme Lumsden
Role: primary
Zina Aladili
Role: primary
Gareth Irwin
Role: primary
Daniel Henderson
Role: primary
Fiona Hoar
Role: primary
Pasupathy Kiriparan
Role: primary
Ricardo Pardo-Garcia
Role: primary
Richard Linforth
Role: primary
Rathinasabapathy Rathinaezhil
Role: primary
Sasirekha Govindarajulu
Role: primary
Inder Kumar
Role: primary
John Benson
Role: primary
Charlotte Kallaway
Role: primary
Anita Hargreaves
Role: primary
Susan Hignett
Role: primary
Sanjana Masinghe
Role: primary
Emanuele Garreffa
Role: primary
Lynda Wyld
Role: primary
Velin Voynov
Role: primary
Aisling Hennessy
Role: primary
Tareq Abdullah
Role: primary
Carolyn Bedi
Role: primary
Douglas Ferguson
Role: primary
Sunil Amonkar
Role: primary
Rosemary Stevens
Role: primary
Jonathan Horsnell
Role: primary
Biswajit Ray
Role: primary
Kaustuv Das
Role: primary
Nicholas Holford
Role: primary
Werbena Hamilton-Burke
Role: primary
Kartikae Grover
Role: primary
Hussein Tuffaha
Role: primary
Musa Barkeji
Role: primary
Rishi Parmeshwar
Role: primary
Subodh Seth
Role: primary
Emma MacInnes
Role: primary
Monika Kaushik
Role: primary
Saira Khawaja
Role: primary
Lai Cheng Yew
Role: primary
Irene Athanasiou
Role: primary
Debashis Ghosh
Role: primary
Neeraj Garg
Role: primary
Katherine Krupa
Role: primary
Daniel Leff
Role: primary
Ruth James
Role: primary
Anjana Satpathy
Role: primary
Anjana Satpathy
Role: primary
Carolyn Bedi
Role: primary
Shaveta Mehta
Role: primary
Raman Vinayagam
Role: primary
Brinda Sethugavalar
Role: primary
Amanda Taylor
Role: primary
Henry Cain
Role: primary
Grant Harris
Role: primary
Pankaj Roy
Role: primary
Abdulla Alhasso
Role: primary
Saed Ramzi
Role: primary
Edward St John
Role: primary
Tamara Kiernan
Role: primary
Bade Murthy
Role: primary
Jagdeep Singh
Role: primary
Tahir Masudi
Role: primary
George Boundouki
Role: primary
Lee Min Lai
Role: primary
Muhammed Baki
Role: primary
Matei Dordea
Role: primary
Sekhar Marla
Role: primary
Konstantinos Serafeimidis
Role: primary
Zoe Goldthorpe
Role: primary
Lubna Noor
Role: primary
Alastair Thomson
Role: primary
Arunmoy Chakravorty
Role: primary
Daniel Glassman
Role: primary
Abdul Syed
Role: primary
Konstantinos Zacharioudakis
Role: primary
kaiyumars Contractor
Role: primary
Raghavan Vidya
Role: primary
Steven Thrush
Role: primary
Caroline Osborne
Role: primary
Bhavani Rengabashyam
Role: primary
Related Links
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Training video for surgeons to remove the marked node during sentinel node biopsy
Training video for radiologists to mark the node using black dye tattoo
Training video for radiologists to mark the node using clip
ATNEC breast cancer study - Research Nurse and Patient Consultation
ATNEC breast cancer study - Example Doctor and Patient Consultation
Other Identifiers
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NIHR 128311
Identifier Type: -
Identifier Source: org_study_id