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ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy

Status: Recruiting
Location: See all (98) locations...
Intervention Type: Radiation, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• cT1-3N1M0 breast cancer at diagnosis (prior to NACT) by American Joint Committee on Cancer (AJCC) staging 8th edition

• 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:

‣ involved node was marked and removed during SNB; and

⁃ 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.

Locations
Other Locations
Ireland
Beaumont Hospital - Royal College of Surgeons in Ireland
RECRUITING
Dublin
St Luke's Hospital - St Luke's Radiation Oncology Network
RECRUITING
Dublin
St Vincent's University Hospital - St Vincent's Healthcare Group
RECRUITING
Dublin
Galway University Hospitals - Saolta University Health Care Group
RECRUITING
Galway
United Kingdom
Aberdeen Royal Infirmary - NHS Grampian
RECRUITING
Aberdeen
Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust
RECRUITING
Ashford
Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust
RECRUITING
Ashton-under-lyne
University Hospital Crosshouse - NHS Ayrshire and Arran
RECRUITING
Ayr
Basildon University Hospital - Mid and South Essex NHS Foundation Trust
RECRUITING
Basildon
Belfast City Hospital - Belfast Health and Social Care Trust
RECRUITING
Belfast
City Hospital -Sandwell and West Birmingham NHS Trust
RECRUITING
Birmingham
QEHB- University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust
RECRUITING
Blackpool
Royal Bolton Hospital - Bolton NHS Foundation Trust
RECRUITING
Bolton
St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust
RECRUITING
Bradford
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
Southmead Hospital - North Bristol NHS Trust
RECRUITING
Bristol
Burnley General Hospital- East Lancashire Hospitals NHS Trust
RECRUITING
Burnley
Frimley Park Hospital - Frimley Health NHS Foundation Trust
RECRUITING
Camberley
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
RECRUITING
Carlisle
Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust
RECRUITING
Cheltenham
Countess of Chester Hospital - Countess of Chester Hospital NHS Trust
RECRUITING
Chester
Leighton Hospital - Mid Cheshire NHS Foundation Trust
RECRUITING
Crewe
Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust
RECRUITING
Darlington
Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust
RECRUITING
Derby
Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
RECRUITING
Doncaster
Russell's Hall Hospital - The Dudley Group NHS Foundation Trust
RECRUITING
Dudley
Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway
RECRUITING
Dumfries
Queen Margert Hospital - NHS Fife
ACTIVE_NOT_RECRUITING
Dunfermline
University Hospital Hairmyres - NHS Lanarkshire
RECRUITING
East Kilbride
Western General Hospital -NHS Lothian
RECRUITING
Edinburgh
Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust
RECRUITING
Exeter
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
RECRUITING
Gateshead
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
RECRUITING
Glasgow
James Paget Hospital -James Paget University Hospitals NHS Foundation Trust
RECRUITING
Great Yarmouth
Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust
RECRUITING
Guildford
Harrogate District Hospital - Harrogate and District NHS Foundation Trust
RECRUITING
Harrogate
Hereford County Hospital- Wye Valley NHS Trust
RECRUITING
Hereford
Wycombe Hospital - Buckinghamshire Healthcare NHS Trust
RECRUITING
High Wycombe
Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust
RECRUITING
Huddersfield
Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Raigmore Hospital - NHS Highland
RECRUITING
Inverness
Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust
RECRUITING
Ipswich
West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust
RECRUITING
Isleworth
Airedale General Hospital - Airedale NHS Foundation Trust
RECRUITING
Keighley
Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust
RECRUITING
Lancaster
Forth Valley Royal Hospital - NHS Forth Valley
RECRUITING
Larbert
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Glenfield Hospital - University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Lincoln
Prince Phillip Hospital -Hywel Dda University Health Board
RECRUITING
Llanelli
Charing Cross Hospital -Imperial College Healthcare NHS Trust
RECRUITING
London
Kings College Hospital - King's College Hospital NHS Foundation Trust
RECRUITING
London
North Middlesex University Hospital - North Middlesex University Hospital NHS Trust
RECRUITING
London
Royal Free Hospital - Royal Free London NHS Foundation Trust
RECRUITING
London
The Royal Marsden NHS Foundation Trust
RECRUITING
London
The Whittington Hospital - Whittington Health NHS Trust
RECRUITING
London
UCL Hospital - University College London Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust
RECRUITING
Luton
Macclesfield District General Hospital - East Cheshire NHS Trust
RECRUITING
Macclesfield
North Manchester General -Manchester University NHS Foundation Trust
RECRUITING
Manchester
Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust
RECRUITING
Manchester
Borders General Hospital -NHS Borders
RECRUITING
Melrose
Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust
RECRUITING
Metropolitan Borough Of Wirral
Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust
RECRUITING
Metropolitan Borough Of Wirral
The James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
RECRUITING
Middlesbrough
Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust
RECRUITING
Milton Keynes
Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust
RECRUITING
North Shields
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Royal Alexandra Hospital - NHS Greater Glasgow and Clyde
RECRUITING
Paisley
Derriford Hospital - University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust
RECRUITING
Portsmouth
St Helen's Hospital - St Helens and Knowsley Teaching Hospitals NHS Trust
RECRUITING
Prescot
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
RECRUITING
Preston
Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust
RECRUITING
Reading
East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust
RECRUITING
Redhill
Rotherham General Hospital - The Rotherham NHS Foundation Trust
RECRUITING
Rotherham
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust
RECRUITING
Shrewsbury
St Alban's Hospital - West Hertfordshire Hospitals NHS Trust
RECRUITING
St Albans
Lister Hospital - East and North Hertfordshire NHS Foundation Trust
RECRUITING
Stevenage
University Hospital North Tees - North Tees and Hartlepool NHS Foundation Trust
RECRUITING
Stockton-on-tees
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Singleton hospital - Swansea Bay University Health Board
RECRUITING
Swansea
Musgrove park Hospital -Somerset NHS Foundation Trust
RECRUITING
Taunton
Croydon University Hospital - Croydon Health Services NHS Trust
RECRUITING
Thornton Heath
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
RECRUITING
Truro
Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust
RECRUITING
Uxbridge
Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust
RECRUITING
Wakefield
Southend Hospital and Broomfield Hospital -Mid and South Essex NHS Foundation Trust
RECRUITING
Westcliff-on-sea
Royal Albert Edward Infirmary - Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
RECRUITING
Wigan
King Edward VII Hospital - Frimley Health NHS Foundation Trust
RECRUITING
Windsor
New Cross Hospital - The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust
RECRUITING
Worcester
Yeovil District Hospital -Yeovil District Hospital NHS Trust
RECRUITING
Yeovil
York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust
RECRUITING
York
Contact Information
Primary
Amit Goyal, MS, MD, FRCS
amit.goyal@nhs.net
+44 1332785538
Time Frame
Start Date: 2021-02-26
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 1900
Treatments
Experimental: 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.
Active_comparator: Axillary treatment
Patients in this arm will receive axillary treatment. Axillary treatment can be axillary lymph node dissection or axillary radiotherapy.
Related Therapeutic Areas
Sponsors
Leads: University Hospitals of Derby and Burton NHS Foundation Trust

This content was sourced from clinicaltrials.gov