Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

NCT04109079 | Recruiting DMC

• 1 other identifier: NIHR 128311
• Study Type: interventional
• Target: 1,900
• Locations: 2 countries
• Sites: 98

Brief 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.

Conditions

Neoplasm, Breast; Breast Cancer; Sentinel Lymph Node

Keywords

neoadjuvant chemotherapy; sentinel node biopsy; breast cancer; tattooing node; marking node; clip node; axillary ultrasound; node positive; axillary lymph node dissection; axillary radiotherapy; axillary treatment

Outcome Measures

Primary Outcomes (2)

• Disease free survival (DFS)

  DFS calculated as the time from randomisation until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.

  5 years

• Patient reported lymphoedema

  Lymphoedema is self-reported based on two items from the validated Lymphoedema and Breast Cancer Questionnaire (arm "swelling now" and arm "heaviness in the past year"). Lymphoedema is defined as 'yes' to both questions.

  5 years

Secondary Outcomes (9)

• Arm function

  5 years

• Health related quality of life: EQ-5D-5L

  5 years

• Axillary recurrence free interval

  5 years

• Overall survival

  5 years

• Local (breast or chest wall) recurrence

  5 years

Study Arms (2)

No axillary treatment

EXPERIMENTAL

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.

Radiation: Breast or chest wall radiotherapy

Axillary treatment

ACTIVE COMPARATOR

Patients in this arm will receive axillary treatment. Axillary treatment can be axillary lymph node dissection or axillary radiotherapy.

Procedure: Axillary lymph node dissection; Radiation: Axillary radiotherapy; Radiation: Breast or chest wall radiotherapy

Interventions

Breast or chest wall radiotherapy RADIATION

Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.

Axillary treatment; No axillary treatment

Axillary lymph node dissection PROCEDURE

Participants will undergo removal of at least level I and II axillary lymph nodes.

Axillary treatment

Axillary radiotherapy RADIATION

Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.

Axillary treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Male or female
• cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)
• o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are eligible for the study.
• 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.
• 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.

You may not qualify if:

• Participants will be excluded if they have any one of the following:
• Bilateral synchronous invasive breast cancer
• Sentinel node biopsy prior to NACT
• Previous axillary nodal surgery on the same body side as the scheduled targeted sampling
• Any previous cancer within last 5 years or concomitant malignancy except
• basal or squamous cell carcinoma of the skin
• in situ carcinoma of the cervix
• in situ or stage 1 melanoma
• contra- or ipsilateral in situ breast cancer
• chronic lymphocytic leukaemia not on treatment

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead

Study Sites (98)

St Vincent's University Hospital - St Vincent's Healthcare Group

Dublin, D04 T6F4, Ireland

RECRUITING

St Luke's Hospital - St Luke's Radiation Oncology Network

Dublin, D06 HH36, Ireland

RECRUITING

Beaumont Hospital - Royal College of Surgeons in Ireland

Dublin, D09 V2N0, Ireland

RECRUITING

Galway University Hospitals - Saolta University Health Care Group

Galway, H91 YR71, Ireland

RECRUITING

Airedale General Hospital - Airedale NHS Foundation Trust

Keighley, BD20 6TD, United Kingdom

RECRUITING

Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust

Carlisle, CA2 7HY, United Kingdom

RECRUITING

Frimley Park Hospital - Frimley Health NHS Foundation Trust

Camberley, GU16 7UJ, United Kingdom

RECRUITING

Raigmore Hospital - NHS Highland

Inverness, IV2 3UJ, United Kingdom

RECRUITING

James Paget Hospital -James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, NR31 6LA, United Kingdom

RECRUITING

Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

RECRUITING

Macclesfield District General Hospital - East Cheshire NHS Trust

Macclesfield, SK10 3BL., United Kingdom

RECRUITING

Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust

Shrewsbury, SY3 8XQ, United Kingdom

RECRUITING

Aberdeen Royal Infirmary - NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust

Ashford, TW15 3AA, United Kingdom

RECRUITING

Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust

Ashton-under-Lyne, OL6 9RW, United Kingdom

RECRUITING

University Hospital Crosshouse - NHS Ayrshire and Arran

Ayr, KA6 6DX, United Kingdom

RECRUITING

Basildon University Hospital - Mid and South Essex NHS Foundation Trust

Basildon, SS16 5NL, United Kingdom

RECRUITING

Belfast City Hospital - Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

RECRUITING

QEHB- University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

City Hospital -Sandwell and West Birmingham NHS Trust

Birmingham, B18 7QH, United Kingdom

RECRUITING

Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

RECRUITING

Royal Bolton Hospital - Bolton NHS Foundation Trust

Bolton, BL4 0JR, United Kingdom

RECRUITING

St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD5 0NA, United Kingdom

RECRUITING

Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 5BE, United Kingdom

RECRUITING

Southmead Hospital - North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

RECRUITING

Burnley General Hospital- East Lancashire Hospitals NHS Trust

Burnley, BB10 2PQ, United Kingdom

RECRUITING

Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust

Cheltenham, GL53 7AN, United Kingdom

RECRUITING

Countess of Chester Hospital - Countess of Chester Hospital NHS Trust

Chester, CH2 1HJ, United Kingdom

RECRUITING

Leighton Hospital - Mid Cheshire NHS Foundation Trust

Crewe, CW1 4QJ, United Kingdom

RECRUITING

Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust

Darlington, DL3 6HX, United Kingdom

RECRUITING

Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust

Derby, DE22 3NE, United Kingdom

RECRUITING

Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, DN2 5LT, United Kingdom

RECRUITING

Russell's Hall Hospital - The Dudley Group NHS Foundation Trust

Dudley, DY1 2HQ, United Kingdom

RECRUITING

Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway

Dumfries, DG2 8RX, United Kingdom

RECRUITING

Queen Margert Hospital - NHS Fife

Dunfermline, KY12 0SU, United Kingdom

ACTIVE NOT RECRUITING

University Hospital Hairmyres - NHS Lanarkshire

East Kilbride, G75 8RG, United Kingdom

RECRUITING

Western General Hospital -NHS Lothian

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

RECRUITING

Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust

Gateshead, NE9 6SX, United Kingdom

RECRUITING

Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

Glasgow, G12 0YN, United Kingdom

RECRUITING

Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

RECRUITING

Harrogate District Hospital - Harrogate and District NHS Foundation Trust

Harrogate, HG2 7SX, United Kingdom

RECRUITING

Hereford County Hospital- Wye Valley NHS Trust

Hereford, HR1 2ER, United Kingdom

RECRUITING

Wycombe Hospital - Buckinghamshire Healthcare NHS Trust

High Wycombe, HP11 2TT, United Kingdom

RECRUITING

Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, HD3 3EA, United Kingdom

RECRUITING

Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust

Hull, HU16 5JQ, United Kingdom

RECRUITING

Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust

Ipswich, IP4 5PD, United Kingdom

RECRUITING

West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust

Isleworth, TW7 6AF, United Kingdom

RECRUITING

Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust

Lancaster, LA1 4RP, United Kingdom

RECRUITING

Forth Valley Royal Hospital - NHS Forth Valley

Larbert, FK5 4WR, United Kingdom

RECRUITING

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Glenfield Hospital - University Hospitals of Leicester NHS Trust

Leicester, LE3 9QP, United Kingdom

RECRUITING

Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust

Lincoln, LN2 5QY, United Kingdom

ACTIVE NOT RECRUITING

Prince Phillip Hospital -Hywel Dda University Health Board

Llanelli, SA14 8QF, United Kingdom

RECRUITING

North Middlesex University Hospital - North Middlesex University Hospital NHS Trust

London, N18 1QX, United Kingdom

RECRUITING

The Whittington Hospital - Whittington Health NHS Trust

London, N19 5NF, United Kingdom

RECRUITING

UCL Hospital - University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

ACTIVE NOT RECRUITING

Royal Free Hospital - Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Kings College Hospital - King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SM2 5PT, United Kingdom

RECRUITING

Charing Cross Hospital -Imperial College Healthcare NHS Trust

London, W6 8RF, United Kingdom

RECRUITING

Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust

Luton, LU4 0DZ, United Kingdom

RECRUITING

Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

RECRUITING

North Manchester General -Manchester University NHS Foundation Trust

Manchester, M8 5RB, United Kingdom

RECRUITING

Borders General Hospital -NHS Borders

Melrose, TD6 9BS, United Kingdom

RECRUITING

Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

RECRUITING

Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

RECRUITING

The James Cook University Hospital - South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

RECRUITING

Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust

Milton Keynes, MK6 5LD, United Kingdom

RECRUITING

Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust

North Shields, NE29 8NH, United Kingdom

RECRUITING

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

RECRUITING

Royal Alexandra Hospital - NHS Greater Glasgow and Clyde

Paisley, PA2 9PN, United Kingdom

RECRUITING

Derriford Hospital - University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

St Helen's Hospital - St Helens and Knowsley Teaching Hospitals NHS Trust

Prescot, L35 5DR, United Kingdom

RECRUITING

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR2 9HT, United Kingdom

RECRUITING

East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust

Redhill, RH1 5RH, United Kingdom

RECRUITING

Rotherham General Hospital - The Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

RECRUITING

Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2SJ, United Kingdom

RECRUITING

St Alban's Hospital - West Hertfordshire Hospitals NHS Trust

St Albans, AL3 5PN, United Kingdom

RECRUITING

Lister Hospital - East and North Hertfordshire NHS Foundation Trust

Stevenage, SG1 4AB, United Kingdom

RECRUITING

University Hospital North Tees - North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

Singleton hospital - Swansea Bay University Health Board

Swansea, SA2 8QA, United Kingdom

RECRUITING

Musgrove park Hospital -Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

RECRUITING

Croydon University Hospital - Croydon Health Services NHS Trust

Thornton Heath, CR7 7YE, United Kingdom

RECRUITING

Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

Truro, TR1 3LJ, United Kingdom

RECRUITING

Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust

Uxbridge, UB8 3NN, United Kingdom

RECRUITING

Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust

Wakefield, WF1 4DG, United Kingdom

RECRUITING

Southend Hospital and Broomfield Hospital -Mid and South Essex NHS Foundation Trust

Westcliff-on-Sea, SS0 0RY, United Kingdom

RECRUITING

Royal Albert Edward Infirmary - Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN1 2NN, United Kingdom

RECRUITING

King Edward VII Hospital - Frimley Health NHS Foundation Trust

Windsor, SL4 3DP, United Kingdom

RECRUITING

New Cross Hospital - The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust

Worcester, WR5 1JR, United Kingdom

RECRUITING

Yeovil District Hospital -Yeovil District Hospital NHS Trust

Yeovil, BA21 4AT, United Kingdom

RECRUITING

York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust

York, YO31 8HE, United Kingdom

RECRUITING

Related Links

• 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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amit Goyal, MS, MD, FRCS

  Royal Derby Hospital, Derby, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Goyal, MS, MD, FRCS

CONTACT

+44 1332785538; amit.goyal@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Oncoplastic Breast Surgeon & Associate Professor

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: September 30, 2019
• Study Start: February 26, 2021
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (4); GB (94)