At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Axillary lymph node dissection (procedure), Axillary radiotherapy (radiation), Breast or chest wall radiotherapy (radiation)
- How long the study runs
- Study runs about 108 months (dates as stated)
- About the drug or intervention
- Axillary lymph node dissection — procedure: Participants will undergo removal of at least level I and II axillary lymph nodes. · Axillary radiotherapy — radiation: Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines. · Breast or chest wall radiotherapy — radiation: Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is for people with breast cancer that had spread to lymph nodes (glands) under the arm, confirmed by a needle biopsy, before chemotherapy. Everyone in the study had chemotherapy before surgery, and the trial looks at how the armpit lymph nodes were managed after treatment. It is sponsored by University Hospitals of Derby and Burton NHS Foundation Trust.
Who can take part
- Adults aged 18 or over, male or female
- Breast cancer diagnosed as cT1-3N1M0 (a certain stage of breast cancer) before chemotherapy, using AJCC 8th edition staging
- People with no obvious cancer in the breast itself, but with cancer spread to armpit nodes proven by needle biopsy, can also take part
- Cancer spread to armpit lymph nodes confirmed by fine needle aspiration (FNA) or core biopsy before treatment
- Hormone receptor (oestrogen receptor) and HER2 status tested on the main tumour
- Received standard chemotherapy before surgery (neoadjuvant chemotherapy, or NACT) — people having hormone therapy before surgery as part of another trial can also take part
- Had scans of the armpit to check how the cancer responded to chemotherapy
- Had a sentinel lymph node biopsy (removal of the first lymph nodes cancer would spread to) after chemotherapy, using two tracers (dyes), with at least 3 nodes removed
- If only one tracer was used: the affected node must have been marked before or during chemotherapy, and at least 3 nodes (including the marked one) removed
- If the node was not marked or the marked node was not removed: the tissue report must show signs the cancer responded (e.g. scarring or fibrosis) in at least one node, with at least 3 nodes removed
- If fewer than 3 nodes were found: the affected node must have been marked and removed, and that node must show signs of response such as scarring
- If the sentinel node could not be found, a sample of armpit nodes must have been taken, with at least 3 nodes removed
- No signs of cancer in the lymph nodes after chemotherapy (no isolated tumour cells, micro or macro metastasis)
- People whose lymph nodes fully cleared but who still had some cancer left in the breast can take part
- People who had no cancer in their nodes at the start but whose sentinel node after chemotherapy was clear and showed signs of response, with at least 3 nodes removed, can take part
Who may not be able to
- Cancer in both breasts at the same time
- Sentinel lymph node biopsy before chemotherapy
- Previous lymph node surgery in the same armpit as the planned sampling
- Any other cancer in the last 5 years, or another cancer at the same time — except some skin cancers, early cervical cancer, early melanoma, non-invasive breast cancer, or chronic lymphocytic leukaemia not on treatment
What taking part involves
- • Chemotherapy before surgery (neoadjuvant chemotherapy, or NACT) given as standard care
- • Sentinel lymph node biopsy after chemotherapy, using tracers to find the nodes, with at least 3 nodes removed
- • In some cases, marking of the affected node before or during chemotherapy so it can be found and removed
- • If the sentinel node cannot be found, a sample of armpit lymph nodes is taken instead
Time commitment: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,900
- Started
- 2021-02-26
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer
- • NA - 1,900 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer
Where?
- • Keighley - Airedale General Hospital - Airedale NHS Foundation Trust
- • Carlisle - Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
- • Camberley - Frimley Park Hospital - Frimley Health NHS Foundation Trust
- • Inverness - Raigmore Hospital - NHS Highland
- • +90 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Background: The presence of cancer in the axillary lymph nodes on needle biopsy in patients with early stage breast cancer before neoadjuvant chemotherapy (NACT) has been the determinant of the need for axillary treatment (in the form of axillary lymph node dissection (ALND) or axillary radiotherapy (ART)) after completion of NACT. Treatment to the axilla damages lymphatic drainage from the arm and patients can subsequently develop lymphoedema, restricted shoulder movement, pain, numbness, and other sensory problems. As more effective chemotherapy is now available that results in complete eradication of cancer in the axilla in around 40 to 70% of patients, extensive axillary treatment might no longer be necessary in patients with no evidence of residual nodal disease. 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓FNA or core biopsy confirmed axillary nodal metastases at presentation
See the full criteria
Where Is This Study? (94 UK sites)
Airedale General Hospital - Airedale NHS Foundation Trust
Keighley, United Kingdom
Mechele Couch-Upite
anhsft.researchanddevelopment@nhs.net01535 292278 / 01535 294655Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
Carlisle, United Kingdom
Research and Development Team research@ncic.nhs.uk
nencadmin@nihr.ac.uk01228 523444Frimley Park Hospital - Frimley Health NHS Foundation Trust
Camberley, United Kingdom
Raigmore Hospital - NHS Highland
Inverness, United Kingdom
James Paget Hospital -James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom
Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust
Reading, United Kingdom
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449Macclesfield District General Hospital - East Cheshire NHS Trust
Macclesfield, United Kingdom
Head of Clinical Governance
ecn-tr.ResearchandDevelopment@nhs.net01625 661018Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust
Shrewsbury, United Kingdom
Aberdeen Royal Infirmary - NHS Grampian
Aberdeen AB25 2ZN, United Kingdom
Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford TW15 3AA, United Kingdom
Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne OL6 9RW, United Kingdom
University Hospital Crosshouse - NHS Ayrshire and Arran
Ayr KA6 6DX, United Kingdom
Basildon University Hospital - Mid and South Essex NHS Foundation Trust
Basildon SS16 5NL, United Kingdom
Belfast City Hospital - Belfast Health and Social Care Trust
Belfast BT9 7AB, United Kingdom
QEHB- University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2GW, United Kingdom
City Hospital -Sandwell and West Birmingham NHS Trust
Birmingham B18 7QH, United Kingdom
Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
Royal Bolton Hospital - Bolton NHS Foundation Trust
Bolton BL4 0JR, United Kingdom
Alison Loftus. R&D Co-ordinator
alison.loftus@boltonft.nhs.uk01204 390390 ext. 3848St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust
Bradford BD5 0NA, United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton BN2 5BE, United Kingdom
Southmead Hospital - North Bristol NHS Trust
Bristol BS10 5NB, United Kingdom
Burnley General Hospital- East Lancashire Hospitals NHS Trust
Burnley BB10 2PQ, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust
Cheltenham GL53 7AN, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Countess of Chester Hospital - Countess of Chester Hospital NHS Trust
Chester CH2 1HJ, United Kingdom
Leighton Hospital - Mid Cheshire NHS Foundation Trust
Crewe CW1 4QJ, United Kingdom
Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust
Darlington DL3 6HX, United Kingdom
Research and Development Team cdda-tr.Research@nhs.net
nencadmin@nihr.ac.uk01325 743366Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust
Derby DE22 3NE, United Kingdom
Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster DN2 5LT, United Kingdom
Dr Jane Fearnside - Head of Research
dbth.clinicalresearch@nhs.net01302 644069Russell's Hall Hospital - The Dudley Group NHS Foundation Trust
Dudley DY1 2HQ, United Kingdom
Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway
Dumfries DG2 8RX, United Kingdom
Queen Margert Hospital - NHS Fife
Dunfermline KY12 0SU, United Kingdom
University Hospital Hairmyres - NHS Lanarkshire
East Kilbride G75 8RG, United Kingdom
Western General Hospital -NHS Lothian
Edinburgh EH4 2XU, United Kingdom
Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust
Exeter EX2 5DW, United Kingdom
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
Gateshead NE9 6SX, United Kingdom
Research and Development Team ghnt.researchanddevelopment@nhs.net
ghnt.researchanddevelopment@nhs.net0191 4820000Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow G12 0YN, United Kingdom
Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust
Guildford GU2 7XX, United Kingdom
Harrogate District Hospital - Harrogate and District NHS Foundation Trust
Harrogate HG2 7SX, United Kingdom
Hereford County Hospital- Wye Valley NHS Trust
Hereford HR1 2ER, United Kingdom
Kym Teale, Research Manager
clinical.trials@wvt.nhs.uk01432 355444 Ext 5279Wycombe Hospital - Buckinghamshire Healthcare NHS Trust
High Wycombe HP11 2TT, United Kingdom
Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust
Huddersfield HD3 3EA, United Kingdom
Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust
Hull HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust
Ipswich IP4 5PD, United Kingdom
West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust
Isleworth TW7 6AF, United Kingdom
Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster LA1 4RP, United Kingdom
Forth Valley Royal Hospital - NHS Forth Valley
Larbert FK5 4WR, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
Glenfield Hospital - University Hospitals of Leicester NHS Trust
Leicester LE3 9QP, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust
Lincoln LN2 5QY, United Kingdom
Prince Phillip Hospital -Hywel Dda University Health Board
Llanelli SA14 8QF, United Kingdom
North Middlesex University Hospital - North Middlesex University Hospital NHS Trust
London N18 1QX, United Kingdom
The Whittington Hospital - Whittington Health NHS Trust
London N19 5NF, United Kingdom
UCL Hospital - University College London Hospitals NHS Foundation Trust
London NW1 2BU, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Royal Free Hospital - Royal Free London NHS Foundation Trust
London NW3 2QG, United Kingdom
Kings College Hospital - King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
The Royal Marsden NHS Foundation Trust
London SM2 5PT, United Kingdom
Charing Cross Hospital -Imperial College Healthcare NHS Trust
London W6 8RF, United Kingdom
Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust
Luton LU4 0DZ, United Kingdom
Dr. Mohammad Wasil. Assistant Director of RD&I
research.bedford@bedsft.nhs.ukContact:Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust
Manchester M23 9LT, United Kingdom
North Manchester General -Manchester University NHS Foundation Trust
Manchester M8 5RB, United Kingdom
Borders General Hospital -NHS Borders
Melrose TD6 9BS, United Kingdom
Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
The James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough TS4 3BW, United Kingdom
Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust
Milton Keynes MK6 5LD, United Kingdom
Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE1 4LP, United Kingdom
North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust
North Shields NE29 8NH, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
Royal Alexandra Hospital - NHS Greater Glasgow and Clyde
Paisley PA2 9PN, United Kingdom
Derriford Hospital - University Hospitals Plymouth NHS Trust
Plymouth PL6 8DH, United Kingdom
Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust
Portsmouth PO6 3LY, United Kingdom
St Helen's Hospital - St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot L35 5DR, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston PR2 9HT, United Kingdom
East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust
Redhill RH1 5RH, United Kingdom
Rotherham General Hospital - The Rotherham NHS Foundation Trust
Rotherham S60 2UD, United Kingdom
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SJ, United Kingdom
St Alban's Hospital - West Hertfordshire Hospitals NHS Trust
St Albans AL3 5PN, United Kingdom
Lister Hospital - East and North Hertfordshire NHS Foundation Trust
Stevenage SG1 4AB, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069University Hospital North Tees - North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees TS19 8PE, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent ST4 6QG, United Kingdom
Singleton hospital - Swansea Bay University Health Board
Swansea SA2 8QA, United Kingdom
Musgrove park Hospital -Somerset NHS Foundation Trust
Taunton TA1 5DA, United Kingdom
Croydon University Hospital - Croydon Health Services NHS Trust
Thornton Heath CR7 7YE, United Kingdom
Non Portfolio - Michael Chang Portfolio - South West Cluster Office
ch-tr.research@nhs.net0208 401 3610Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
Truro TR1 3LJ, United Kingdom
Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust
Uxbridge UB8 3NN, United Kingdom
Geraldine Landers
thh.research.hillingdon@nhs.net01895 279021/ Ext 3021Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust
Wakefield WF1 4DG, United Kingdom
Southend Hospital and Broomfield Hospital -Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea SS0 0RY, United Kingdom
Royal Albert Edward Infirmary - Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan WN1 2NN, United Kingdom
King Edward VII Hospital - Frimley Health NHS Foundation Trust
Windsor SL4 3DP, United Kingdom
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton WV10 0QP, United Kingdom
Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust
Worcester WR5 1JR, United Kingdom
Yeovil District Hospital -Yeovil District Hospital NHS Trust
Yeovil BA21 4AT, United Kingdom
York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust
York YO31 8HE, United Kingdom
How to Get in Touch
Amit Goyal, MS, MD, FRCS
Sponsor contactCONTACT
