AzTrials
AzTrials

Breast CancerATNECNCT04109079

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

A study testing Axillary lymph node dissection, Axillary radiotherapy and Breast or chest wall radiotherapy in people with Breast Cancer and Sentinel Lymph Node, run by University Hospitals of Derby and Burton NHS Foundation Trust at 98 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axillary lymph node dissection, Axillary radiotherapy and Breast or chest wall radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,900 participants
Where
98 sitesin 2 countries
Study dates
26 Feb 2021to 28 Feb 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 29Show fewer
  • 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.
  • 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

Who cannot join

None listed.

Trial locations and contacts

98 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Amit Goyal, MS, MD, FRCS contact

+44 1332785538

amit.goyal@nhs.net

98 sites in 2 countries

United Kingdom94 sites, 91 recruiting

  • Aberdeen Royal Infirmary - NHS Grampian

    Aberdeen, AB25 2ZN

    Beatrix Elsberger

    Recruiting

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

    Ashford, TW15 3AA

    Anneliese Lawn

    Recruiting

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

    Ashton-under-Lyne, OL6 9RW

    Pardeep Arora

    Recruiting

  • University Hospital Crosshouse - NHS Ayrshire and Arran

    Ayr, KA6 6DX

    Graeme Lumsden

    Recruiting

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

    Basildon, SS16 5NL

    Zina Aladili

    Recruiting

  • Belfast City Hospital - Belfast Health and Social Care Trust

    Belfast, BT9 7AB

    Gareth Irwin

    Recruiting

  • QEHB- University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

    Daniel Henderson

    Recruiting

  • City Hospital -Sandwell and West Birmingham NHS Trust

    Birmingham, B18 7QH

    Fiona Hoar

    Recruiting

  • Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool

    Pasupathy Kiriparan

    Recruiting

  • Royal Bolton Hospital - Bolton NHS Foundation Trust

    Bolton, BL4 0JR

    Ricardo Pardo-Garcia

    Recruiting

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

    Bradford, BD5 0NA

    Richard Linforth

    Recruiting

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

    Brighton, BN2 5BE

    Rathinasabapathy Rathinaezhil

    Recruiting

  • Southmead Hospital - North Bristol NHS Trust

    Bristol, BS10 5NB

    Sasirekha Govindarajulu

    Recruiting

  • Burnley General Hospital- East Lancashire Hospitals NHS Trust

    Burnley, BB10 2PQ

    Inder Kumar

    Recruiting

  • Frimley Park Hospital - Frimley Health NHS Foundation Trust

    Camberley, GU16 7UJ

    Kaiyumars Contractor

    Hisham Osman

    Recruiting

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

    Cambridge, CB2 0QQ

    John Benson

    Recruiting

  • Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust

    Carlisle, CA2 7HY

    Ludger Barthelmes

    Recruiting

  • Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust

    Cheltenham, GL53 7AN

    Charlotte Kallaway

    Recruiting

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

    Chester, CH2 1HJ

    Anita Hargreaves

    Recruiting

  • Leighton Hospital - Mid Cheshire NHS Foundation Trust

    Crewe, CW1 4QJ

    Susan Hignett

    Recruiting

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

    Darlington, DL3 6HX

    Sanjana Masinghe

    Recruiting

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

    Derby, DE22 3NE

    Emanuele Garreffa

    Recruiting

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

    Doncaster, DN2 5LT

    Lynda Wyld

    Recruiting

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

    Dudley, DY1 2HQ

    Velin Voynov

    Recruiting

  • Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway

    Dumfries, DG2 8RX

    Aisling Hennessy

    Recruiting

  • Queen Margert Hospital - NHS Fife

    Dunfermline, KY12 0SU

    Active, not recruiting

  • University Hospital Hairmyres - NHS Lanarkshire

    East Kilbride, G75 8RG

    Tareq Abdullah

    Recruiting

  • Western General Hospital -NHS Lothian

    Edinburgh, EH4 2XU

    Carolyn Bedi

    Recruiting

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

    Exeter, EX2 5DW

    Douglas Ferguson

    Recruiting

  • Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust

    Gateshead, NE9 6SX

    Sunil Amonkar

    Recruiting

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

    Glasgow, G12 0YN

    Rosemary Stevens

    Recruiting

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

    Great Yarmouth, NR31 6LA

    Sue Down

    Recruiting

  • Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust

    Guildford, GU2 7XX

    Jonathan Horsnell

    Recruiting

  • Harrogate District Hospital - Harrogate and District NHS Foundation Trust

    Harrogate, HG2 7SX

    Biswajit Ray

    Recruiting

  • Hereford County Hospital- Wye Valley NHS Trust

    Hereford, HR1 2ER

    Kaustuv Das

    Recruiting

  • Wycombe Hospital - Buckinghamshire Healthcare NHS Trust

    High Wycombe, HP11 2TT

    Nicholas Holford

    Recruiting

  • Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, HD3 3EA

    Werbena Hamilton-Burke

    Recruiting

  • Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust

    Hull, HU16 5JQ

    Kartikae Grover

    Recruiting

  • Raigmore Hospital - NHS Highland

    Inverness, IV2 3UJ

    Eileen Anderson

    Recruiting

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

    Ipswich, IP4 5PD

    Hussein Tuffaha

    Recruiting

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

    Isleworth, TW7 6AF

    Musa Barkeji

    Recruiting

  • Airedale General Hospital - Airedale NHS Foundation Trust

    Keighley, BD20 6TD

    Claire Murphy

    Recruiting

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

    Lancaster, LA1 4RP

    Rishi Parmeshwar

    Recruiting

  • Forth Valley Royal Hospital - NHS Forth Valley

    Larbert, FK5 4WR

    Subodh Seth

    Recruiting

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

    Leeds, LS9 7TF

    Emma MacInnes

    Recruiting

  • Glenfield Hospital - University Hospitals of Leicester NHS Trust

    Leicester, LE3 9QP

    Monika Kaushik

    Recruiting

  • Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust

    Lincoln, LN2 5QY

    Active, not recruiting

  • Prince Phillip Hospital -Hywel Dda University Health Board

    Llanelli, SA14 8QF

    Saira Khawaja

    Recruiting

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

    London, N18 1QX

    Lai Cheng Yew

    Recruiting

  • The Whittington Hospital - Whittington Health NHS Trust

    London, N19 5NF

    Irene Athanasiou

    Recruiting

  • UCL Hospital - University College London Hospitals NHS Foundation Trust

    London, NW1 2BU

    Active, not recruiting

  • Royal Free Hospital - Royal Free London NHS Foundation Trust

    London, NW3 2QG

    Debashis Ghosh

    Recruiting

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

    London, SE5 9RS

    Neeraj Garg

    Recruiting

  • The Royal Marsden NHS Foundation Trust

    London, SM2 5PT

    Katherine Krupa

    Recruiting

  • Charing Cross Hospital -Imperial College Healthcare NHS Trust

    London, W6 8RF

    Daniel Leff

    Recruiting

  • Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust

    Luton, LU4 0DZ

    Ruth James

    Recruiting

  • Macclesfield District General Hospital - East Cheshire NHS Trust

    Macclesfield, SK10 3BL.

    Jalal Kokan

    Recruiting

  • Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust

    Manchester, M23 9LT

    Anjana Satpathy

    Recruiting

  • North Manchester General -Manchester University NHS Foundation Trust

    Manchester, M8 5RB

    Anjana Satpathy

    Recruiting

  • Borders General Hospital -NHS Borders

    Melrose, TD6 9BS

    Carolyn Bedi

    Recruiting

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

    Metropolitan Borough of Wirral, CH63 4JY

    Shaveta Mehta

    Recruiting

  • Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY

    Raman Vinayagam

    Recruiting

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

    Middlesbrough, TS4 3BW

    Brinda Sethugavalar

    Recruiting

  • Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust

    Milton Keynes, MK6 5LD

    Amanda Taylor

    Recruiting

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

    Newcastle upon Tyne, NE1 4LP

    Henry Cain

    Recruiting

  • North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust

    North Shields, NE29 8NH

    Grant Harris

    Recruiting

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

    Pankaj Roy

    Recruiting

  • Royal Alexandra Hospital - NHS Greater Glasgow and Clyde

    Paisley, PA2 9PN

    Abdulla Alhasso

    Recruiting

  • Derriford Hospital - University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH

    Saed Ramzi

    Recruiting

  • Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust

    Portsmouth, PO6 3LY

    Edward St John

    Recruiting

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

    Prescot, L35 5DR

    Tamara Kiernan

    Recruiting

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

    Bade Murthy

    Recruiting

  • Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust

    Reading, RG1 5AN

    Brendan Smith

    Recruiting

  • East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust

    Redhill, RH1 5RH

    Jagdeep Singh

    Recruiting

  • Rotherham General Hospital - The Rotherham NHS Foundation Trust

    Rotherham, S60 2UD

    Tahir Masudi

    Recruiting

  • Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SJ

    George Boundouki

    Recruiting

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

    Shrewsbury, SY3 8XQ

    Laura Pettit

    Recruiting

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

    St Albans, AL3 5PN

    Lee Min Lai

    Recruiting

  • Lister Hospital - East and North Hertfordshire NHS Foundation Trust

    Stevenage, SG1 4AB

    Muhammed Baki

    Recruiting

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

    Stockton-on-Tees, TS19 8PE

    Matei Dordea

    Recruiting

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

    Stoke-on-Trent, ST4 6QG

    Sekhar Marla

    Recruiting

  • Singleton hospital - Swansea Bay University Health Board

    Swansea, SA2 8QA

    Konstantinos Serafeimidis

    Recruiting

  • Musgrove park Hospital -Somerset NHS Foundation Trust

    Taunton, TA1 5DA

    Zoe Goldthorpe

    Recruiting

  • Croydon University Hospital - Croydon Health Services NHS Trust

    Thornton Heath, CR7 7YE

    Lubna Noor

    Recruiting

  • Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust

    Truro, TR1 3LJ

    Alastair Thomson

    Recruiting

  • Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust

    Uxbridge, UB8 3NN

    Arunmoy Chakravorty

    Recruiting

  • Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust

    Wakefield, WF1 4DG

    Daniel Glassman

    Recruiting

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

    Westcliff-on-Sea, SS0 0RY

    Abdul Syed

    Recruiting

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

    Wigan, WN1 2NN

    Konstantinos Zacharioudakis

    Recruiting

  • King Edward VII Hospital - Frimley Health NHS Foundation Trust

    Windsor, SL4 3DP

    kaiyumars Contractor

    Recruiting

  • New Cross Hospital - The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

    Raghavan Vidya

    Recruiting

  • Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust

    Worcester, WR5 1JR

    Steven Thrush

    Recruiting

  • Yeovil District Hospital -Yeovil District Hospital NHS Trust

    Yeovil, BA21 4AT

    Caroline Osborne

    Recruiting

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

    York, YO31 8HE

    Bhavani Rengabashyam

    Recruiting

Other trials in United Kingdom

Ireland4 sites, 4 recruiting

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

    Dublin, D04 T6F4

    Michael Boland

    Recruiting

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

    Dublin, D06 HH36

    John Armstrong

    Recruiting

  • Beaumont Hospital - Royal College of Surgeons in Ireland

    Dublin, D09 V2N0

    Recruiting

  • Galway University Hospitals - Saolta University Health Care Group

    Galway, H91 YR71

    Aoife Lowery

    Recruiting

Other trials in Ireland

About this study

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

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.

Read the detailed description

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.

Being tested
Axillary lymph node dissection, Axillary radiotherapy, Breast or chest wall radiotherapy
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
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary lymph node dissectionProcedure or surgery

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

  • Axillary radiotherapyRadiation

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

  • Breast or chest wall radiotherapyRadiation

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

Study groups in NCT04109079
Study groupRoleWhat they receive
No axillary treatmentExperimentalPatients 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.
Receives: Radiation: Breast or chest wall radiotherapy
Axillary treatmentActive comparatorPatients in this arm will receive axillary treatment. Axillary treatment can be axillary lymph node dissection or axillary radiotherapy.
Receives: Procedure: Axillary lymph node dissection; Radiation: Axillary radiotherapy; Radiation: Breast or chest wall radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

Secondary outcomes (9)

  1. Arm function

    Arm function will be assessed using shortened version of the Disability of the Arm, Shoulder and Hand (DASH), the 11-item QuickDASH questionnaire. Physical disability is defined as a change from baseline in the QuickDASH score of at least 14 points.

    Measured: 5 years

  2. Health related quality of life: EQ-5D-5L

    Health related quality of life will be assessed with EQ-5D-5L

    Measured: 5 years

  3. Axillary recurrence free interval

    Axillary recurrence free interval, calculated from the date of randomisation to the date of axillary recurrence or the censor date.

    Measured: 5 years

  4. Overall survival

    Overall survival calculated as the time from randomisation until the date of death by any cause or the censor date.

    Measured: 5 years

  5. Local (breast or chest wall) recurrence

    Number of participants with local (breast or chest wall) recurrence

    Measured: 5 years

  6. Regional (nodal) recurrence

    Number of participants with regional (nodal) recurrence

    Measured: 5 years

  7. Distant metastasis

    Number of participants with distant metastasis.

    Measured: 5 years

  8. Contralateral breast cancer

    Number of participants with contralateral breast cancer.

    Measured: 5 years

  9. Non-breast cancer

    Number of participants with non-breast cancer

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start26 Feb 2021
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109079
Sponsor's protocol ID
NIHR 128311
Acronym
ATNEC
Status last verified
Mar 2026
First submitted
27 Sep 2019
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Axillary lymph node dissection, Axillary radiotherapy and Breast or chest wall radiotherapy in people with Breast Cancer and Sentinel Lymph Node, run by University Hospitals of Derby and Burton NHS Foundation Trust at 98 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amit Goyal, MS, MD, FRCS (+44 1332785538, amit.goyal@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (DFS) (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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