Actively Recruiting
Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
Led by University Hospitals of Derby and Burton NHS Foundation Trust · Updated on 2026-03-30
1900
Participants Needed
98
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or female
- Diagnosed with cT1-3N1M0 breast cancer at diagnosis as per AJCC 8th edition
- Patients with occult primary invasive breast cancer with FNA or core biopsy proven nodal metastases
- Confirmed axillary nodal metastases by FNA or core biopsy at presentation
- Oestrogen receptor and HER2 status evaluated on primary tumour
- Received standard neoadjuvant chemotherapy as per local guidelines
- Imaging of the axilla performed as required to assess response to NACT
- Dual tracer sentinel node biopsy performed after NACT with removal of at least 3 nodes
- If single tracer sentinel node biopsy was performed, involved node marked before or during NACT and at least 3 nodes removed
- If node not marked or marked node not removed, histology shows down-staging with complete pathological response in at least one node and at least 3 nodes removed
- If fewer than 3 nodes found on histology, involved node was marked and removed during SNB and shows evidence of downstaging
- If sentinel nodes cannot be localized on SNB, axillary node sampling performed with removal of at least 3 nodes
- 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
- Patients who were node negative at initial presentation with negative sentinel node post NACT showing treatment response and at least 3 nodes removed
You will not qualify if you...
- Bilateral synchronous invasive breast cancer
- Sentinel node biopsy performed prior to NACT
- Previous axillary nodal surgery on the same side as 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, or chronic lymphocytic leukaemia not on treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
St Vincent's University Hospital - St Vincent's Healthcare Group
Dublin, Ireland, D04 T6F4
Actively Recruiting
2
St Luke's Hospital - St Luke's Radiation Oncology Network
Dublin, Ireland, D06 HH36
Actively Recruiting
3
Beaumont Hospital - Royal College of Surgeons in Ireland
Dublin, Ireland, D09 V2N0
Actively Recruiting
4
Galway University Hospitals - Saolta University Health Care Group
Galway, Ireland, H91 YR71
Actively Recruiting
5
Airedale General Hospital - Airedale NHS Foundation Trust
Keighley, BD20 6TD, United Kingdom
Actively Recruiting
6
Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
Carlisle, CA2 7HY, United Kingdom
Actively Recruiting
7
Frimley Park Hospital - Frimley Health NHS Foundation Trust
Camberley, GU16 7UJ, United Kingdom
Actively Recruiting
8
Raigmore Hospital - NHS Highland
Inverness, IV2 3UJ, United Kingdom
Actively Recruiting
9
James Paget Hospital -James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
Actively Recruiting
10
Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
Actively Recruiting
11
Macclesfield District General Hospital - East Cheshire NHS Trust
Macclesfield, SK10 3BL., United Kingdom
Actively Recruiting
12
Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust
Shrewsbury, SY3 8XQ, United Kingdom
Actively Recruiting
13
Aberdeen Royal Infirmary - NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
14
Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford, United Kingdom, TW15 3AA
Actively Recruiting
15
Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust
Ashton-under-Lyne, United Kingdom, OL6 9RW
Actively Recruiting
16
University Hospital Crosshouse - NHS Ayrshire and Arran
Ayr, United Kingdom, KA6 6DX
Actively Recruiting
17
Basildon University Hospital - Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom, SS16 5NL
Actively Recruiting
18
Belfast City Hospital - Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
19
QEHB- University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
20
City Hospital -Sandwell and West Birmingham NHS Trust
Birmingham, United Kingdom, B18 7QH
Actively Recruiting
21
Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
Actively Recruiting
22
Royal Bolton Hospital - Bolton NHS Foundation Trust
Bolton, United Kingdom, BL4 0JR
Actively Recruiting
23
St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom, BD5 0NA
Actively Recruiting
24
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
25
Southmead Hospital - North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
26
Burnley General Hospital- East Lancashire Hospitals NHS Trust
Burnley, United Kingdom, BB10 2PQ
Actively Recruiting
27
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
28
Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust
Cheltenham, United Kingdom, GL53 7AN
Actively Recruiting
29
Countess of Chester Hospital - Countess of Chester Hospital NHS Trust
Chester, United Kingdom, CH2 1HJ
Actively Recruiting
30
Leighton Hospital - Mid Cheshire NHS Foundation Trust
Crewe, United Kingdom, CW1 4QJ
Actively Recruiting
31
Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust
Darlington, United Kingdom, DL3 6HX
Actively Recruiting
32
Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom, DE22 3NE
Actively Recruiting
33
Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, United Kingdom, DN2 5LT
Actively Recruiting
34
Russell's Hall Hospital - The Dudley Group NHS Foundation Trust
Dudley, United Kingdom, DY1 2HQ
Actively Recruiting
35
Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway
Dumfries, United Kingdom, DG2 8RX
Actively Recruiting
36
Queen Margert Hospital - NHS Fife
Dunfermline, United Kingdom, KY12 0SU
Active, Not Recruiting
37
University Hospital Hairmyres - NHS Lanarkshire
East Kilbride, United Kingdom, G75 8RG
Actively Recruiting
38
Western General Hospital -NHS Lothian
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
39
Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
40
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom, NE9 6SX
Actively Recruiting
41
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
42
Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
43
Harrogate District Hospital - Harrogate and District NHS Foundation Trust
Harrogate, United Kingdom, HG2 7SX
Actively Recruiting
44
Hereford County Hospital- Wye Valley NHS Trust
Hereford, United Kingdom, HR1 2ER
Actively Recruiting
45
Wycombe Hospital - Buckinghamshire Healthcare NHS Trust
High Wycombe, United Kingdom, HP11 2TT
Actively Recruiting
46
Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom, HD3 3EA
Actively Recruiting
47
Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU16 5JQ
Actively Recruiting
48
Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust
Ipswich, United Kingdom, IP4 5PD
Actively Recruiting
49
West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust
Isleworth, United Kingdom, TW7 6AF
Actively Recruiting
50
Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster, United Kingdom, LA1 4RP
Actively Recruiting
51
Forth Valley Royal Hospital - NHS Forth Valley
Larbert, United Kingdom, FK5 4WR
Actively Recruiting
52
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
53
Glenfield Hospital - University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
54
Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust
Lincoln, United Kingdom, LN2 5QY
Active, Not Recruiting
55
Prince Phillip Hospital -Hywel Dda University Health Board
Llanelli, United Kingdom, SA14 8QF
Actively Recruiting
56
North Middlesex University Hospital - North Middlesex University Hospital NHS Trust
London, United Kingdom, N18 1QX
Actively Recruiting
57
The Whittington Hospital - Whittington Health NHS Trust
London, United Kingdom, N19 5NF
Actively Recruiting
58
UCL Hospital - University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Active, Not Recruiting
59
Royal Free Hospital - Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Actively Recruiting
60
Kings College Hospital - King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
61
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SM2 5PT
Actively Recruiting
62
Charing Cross Hospital -Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Actively Recruiting
63
Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust
Luton, United Kingdom, LU4 0DZ
Actively Recruiting
64
Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Actively Recruiting
65
North Manchester General -Manchester University NHS Foundation Trust
Manchester, United Kingdom, M8 5RB
Actively Recruiting
66
Borders General Hospital -NHS Borders
Melrose, United Kingdom, TD6 9BS
Actively Recruiting
67
Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
68
Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
69
The James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
70
Milton Keynes Hospital - Milton Keynes University Hospital NHS Trust
Milton Keynes, United Kingdom, MK6 5LD
Actively Recruiting
71
Royal Victoria Infirmary- Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
72
North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom, NE29 8NH
Actively Recruiting
73
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
74
Royal Alexandra Hospital - NHS Greater Glasgow and Clyde
Paisley, United Kingdom, PA2 9PN
Actively Recruiting
75
Derriford Hospital - University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
76
Queen Alexandra Hospital - Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Actively Recruiting
77
St Helen's Hospital - St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, United Kingdom, L35 5DR
Actively Recruiting
78
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom, PR2 9HT
Actively Recruiting
79
East Surrey Hospital - Surrey & Sussex Healthcare NHS Trust
Redhill, United Kingdom, RH1 5RH
Actively Recruiting
80
Rotherham General Hospital - The Rotherham NHS Foundation Trust
Rotherham, United Kingdom, S60 2UD
Actively Recruiting
81
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SJ
Actively Recruiting
82
St Alban's Hospital - West Hertfordshire Hospitals NHS Trust
St Albans, United Kingdom, AL3 5PN
Actively Recruiting
83
Lister Hospital - East and North Hertfordshire NHS Foundation Trust
Stevenage, United Kingdom, SG1 4AB
Actively Recruiting
84
University Hospital North Tees - North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
85
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
86
Singleton hospital - Swansea Bay University Health Board
Swansea, United Kingdom, SA2 8QA
Actively Recruiting
87
Musgrove park Hospital -Somerset NHS Foundation Trust
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
88
Croydon University Hospital - Croydon Health Services NHS Trust
Thornton Heath, United Kingdom, CR7 7YE
Actively Recruiting
89
Royal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom, TR1 3LJ
Actively Recruiting
90
Hillingdon Hospital - The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, United Kingdom, UB8 3NN
Actively Recruiting
91
Pinderfields Hospital - Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom, WF1 4DG
Actively Recruiting
92
Southend Hospital and Broomfield Hospital -Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, United Kingdom, SS0 0RY
Actively Recruiting
93
Royal Albert Edward Infirmary - Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom, WN1 2NN
Actively Recruiting
94
King Edward VII Hospital - Frimley Health NHS Foundation Trust
Windsor, United Kingdom, SL4 3DP
Actively Recruiting
95
New Cross Hospital - The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
96
Worcestershire Royal Hospital - Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom, WR5 1JR
Actively Recruiting
97
Yeovil District Hospital -Yeovil District Hospital NHS Trust
Yeovil, United Kingdom, BA21 4AT
Actively Recruiting
98
York Hospital - York and Scarborough Teaching Hospitals NHS Foundation Trust
York, United Kingdom, YO31 8HE
Actively Recruiting
Research Team
A
Amit Goyal, MS, MD, FRCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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