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BREAST CANCER TRIAL TESTS IF LESS AXILLARY TREATMENT IS SAFE AFTER CHEMO

NCT ID NCT04109079

Disease control Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at women and men with early-stage breast cancer that had spread to lymph nodes. After chemotherapy, if a sentinel node biopsy shows no cancer left, the trial compares doing nothing further versus standard axillary lymph node removal or radiation. The goal is to see if skipping extra treatment is just as good for preventing cancer return and reduces arm swelling. About 1,900 participants are being recruited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Axillary lymph node dissection and axillary radiotherapy
What this could lead to
If successful, this could show that many breast cancer patients can safely avoid additional lymph node surgery or radiation after chemotherapy, reducing side effects like arm swelling.
What could go wrong
This is a large but ongoing trial, and results are not yet available. There is a risk that skipping further treatment might lead to higher cancer recurrence rates.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 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. * 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 * Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed. 5.2. Exclusion Criteria 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Neoplasm, breast Sentinel lymph node

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    95 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary - NHS Grampian

    RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Airedale General Hospital - Airedale NHS Foundation Trust

    RECRUITING

    Keighley, BD20 6TD, United Kingdom

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

    RECRUITING

    Ashford, TW15 3AA, United Kingdom

  • Basildon University Hospital - Mid and South Essex NHS Foundation Trust

    RECRUITING

    Basildon, SS16 5NL, United Kingdom

  • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Beaumont Hospital - Royal College of Surgeons in Ireland

    RECRUITING

    Dublin, D09 V2N0, Ireland

  • Belfast City Hospital - Belfast Health and Social Care Trust

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Blackpool, United Kingdom

  • Borders General Hospital -NHS Borders

    RECRUITING

    Melrose, TD6 9BS, United Kingdom

  • Burnley General Hospital- East Lancashire Hospitals NHS Trust

    RECRUITING

    Burnley, BB10 2PQ, United Kingdom

  • Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, HU16 5JQ, United Kingdom

  • Charing Cross Hospital -Imperial College Healthcare NHS Trust

    RECRUITING

    London, W6 8RF, United Kingdom

  • Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust

    RECRUITING

    Cheltenham, GL53 7AN, United Kingdom

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • City Hospital -Sandwell and West Birmingham NHS Trust

    RECRUITING

    Birmingham, B18 7QH, United Kingdom

  • Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Countess of Chester Hospital - Countess of Chester Hospital NHS Trust

    RECRUITING

    Chester, CH2 1HJ, United Kingdom

  • Croydon University Hospital - Croydon Health Services NHS Trust

    RECRUITING

    Thornton Heath, CR7 7YE, United Kingdom

  • Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust

    RECRUITING

    Carlisle, CA2 7HY, United Kingdom

  • Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust

    RECRUITING

    Darlington, DL3 6HX, United Kingdom

  • Derriford Hospital - University Hospitals Plymouth NHS Trust

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

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

    RECRUITING

    Doncaster, DN2 5LT, United Kingdom

  • Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway

    RECRUITING

    Dumfries, DG2 8RX, United Kingdom

  • East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust

    RECRUITING

    Redhill, RH1 5RH, United Kingdom

  • Forth Valley Royal Hospital - NHS Forth Valley

    RECRUITING

    Larbert, FK5 4WR, United Kingdom

  • Frimley Park Hospital - Frimley Health NHS Foundation Trust

    RECRUITING

    Camberley, GU16 7UJ, United Kingdom

  • Galway University Hospitals - Saolta University Health Care Group

    RECRUITING

    Galway, H91 YR71, Ireland

  • Glenfield Hospital - University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, LE3 9QP, United Kingdom

  • Harrogate District Hospital - Harrogate and District NHS Foundation Trust

    RECRUITING

    Harrogate, HG2 7SX, United Kingdom

  • Hereford County Hospital- Wye Valley NHS Trust

    RECRUITING

    Hereford, HR1 2ER, United Kingdom

  • Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust

    RECRUITING

    Uxbridge, UB8 3NN, United Kingdom

  • Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust

    RECRUITING

    Huddersfield, HD3 3EA, United Kingdom

  • Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust

    RECRUITING

    Ipswich, IP4 5PD, United Kingdom

  • James Paget Hospital -James Paget University Hospitals NHS Foundation Trust

    RECRUITING

    Great Yarmouth, NR31 6LA, United Kingdom

  • King Edward VII Hospital - Frimley Health NHS Foundation Trust

    RECRUITING

    Windsor, SL4 3DP, United Kingdom

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

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Leighton Hospital - Mid Cheshire NHS Foundation Trust

    RECRUITING

    Crewe, CW1 4QJ, United Kingdom

  • Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust

    ACTIVE_NOT_RECRUITING

    Lincoln, LN2 5QY, United Kingdom

  • Lister Hospital - East and North Hertfordshire NHS Foundation Trust

    RECRUITING

    Stevenage, SG1 4AB, United Kingdom

  • Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust

    RECRUITING

    Luton, LU4 0DZ, United Kingdom

  • Macclesfield District General Hospital - East Cheshire NHS Trust

    RECRUITING

    Macclesfield, SK10 3BL., United Kingdom

  • Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust

    RECRUITING

    Milton Keynes, MK6 5LD, United Kingdom

  • Musgrove park Hospital -Somerset NHS Foundation Trust

    RECRUITING

    Taunton, TA1 5DA, United Kingdom

  • New Cross Hospital - The Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • North Manchester General -Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, M8 5RB, United Kingdom

  • North Middlesex University Hospital - North Middlesex University Hospital NHS Trust

    RECRUITING

    London, N18 1QX, United Kingdom

  • North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust

    RECRUITING

    North Shields, NE29 8NH, United Kingdom

  • Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust

    RECRUITING

    Wakefield, WF1 4DG, United Kingdom

  • Prince Phillip Hospital -Hywel Dda University Health Board

    RECRUITING

    Llanelli, SA14 8QF, United Kingdom

  • QEHB- University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust

    RECRUITING

    Portsmouth, PO6 3LY, United Kingdom

  • Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust

    RECRUITING

    Gateshead, NE9 6SX, United Kingdom

  • Queen Margert Hospital - NHS Fife

    ACTIVE_NOT_RECRUITING

    Dunfermline, KY12 0SU, United Kingdom

  • Raigmore Hospital - NHS Highland

    RECRUITING

    Inverness, IV2 3UJ, United Kingdom

  • Rotherham General Hospital - The Rotherham NHS Foundation Trust

    RECRUITING

    Rotherham, S60 2UD, United Kingdom

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

    RECRUITING

    Wigan, WN1 2NN, United Kingdom

  • Royal Alexandra Hospital - NHS Greater Glasgow and Clyde

    RECRUITING

    Paisley, PA2 9PN, United Kingdom

  • Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust

    RECRUITING

    Reading, RG1 5AN, United Kingdom

  • Royal Bolton Hospital - Bolton NHS Foundation Trust

    RECRUITING

    Bolton, BL4 0JR, United Kingdom

  • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

    RECRUITING

    Truro, TR1 3LJ, United Kingdom

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

    RECRUITING

    Derby, DE22 3NE, United Kingdom

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

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Free Hospital - Royal Free London NHS Foundation Trust

    RECRUITING

    London, NW3 2QG, United Kingdom

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

    RECRUITING

    Lancaster, LA1 4RP, United Kingdom

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Preston, PR2 9HT, United Kingdom

  • Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust

    RECRUITING

    Shrewsbury, SY3 8XQ, United Kingdom

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

    RECRUITING

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

  • Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust

    RECRUITING

    Guildford, GU2 7XX, United Kingdom

  • Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

    RECRUITING

    Brighton, BN2 5BE, United Kingdom

  • Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

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

    RECRUITING

    Dudley, DY1 2HQ, United Kingdom

  • Singleton hospital - Swansea Bay University Health Board

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

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

    RECRUITING

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

  • Southmead Hospital - North Bristol NHS Trust

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • St Alban's Hospital - West Hertfordshire Hospitals NHS Trust

    RECRUITING

    St Albans, AL3 5PN, United Kingdom

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

    RECRUITING

    Prescot, L35 5DR, United Kingdom

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

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

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

    RECRUITING

    Bradford, BD5 0NA, United Kingdom

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

    RECRUITING

    Dublin, D06 HH36, Ireland

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

    RECRUITING

    Dublin, D04 T6F4, Ireland

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

    RECRUITING

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

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

    RECRUITING

    Middlesbrough, TS4 3BW, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SM2 5PT, United Kingdom

  • The Whittington Hospital - Whittington Health NHS Trust

    RECRUITING

    London, N19 5NF, United Kingdom

  • UCL Hospital - University College London Hospitals NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital Crosshouse - NHS Ayrshire and Arran

    RECRUITING

    Ayr, KA6 6DX, United Kingdom

  • University Hospital Hairmyres - NHS Lanarkshire

    RECRUITING

    East Kilbride, G75 8RG, United Kingdom

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

    RECRUITING

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

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

    RECRUITING

    Isleworth, TW7 6AF, United Kingdom

  • Western General Hospital -NHS Lothian

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2SJ, United Kingdom

  • Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust

    RECRUITING

    Worcester, WR5 1JR, United Kingdom

  • Wycombe Hospital - Buckinghamshire Healthcare NHS Trust

    RECRUITING

    High Wycombe, HP11 2TT, United Kingdom

  • Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Yeovil District Hospital -Yeovil District Hospital NHS Trust

    RECRUITING

    Yeovil, BA21 4AT, United Kingdom

  • York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust

    RECRUITING

    York, YO31 8HE, United Kingdom

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