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

Primary Purpose

Breast Cancer, Sentinel Lymph Node, Neoplasm, Breast

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Axillary lymph node dissection
Axillary radiotherapy
Breast or chest wall radiotherapy
Sponsored by
University Hospitals of Derby and Burton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T1-3N1M0 breast cancer at diagnosis (prior to NACT) by American Joint Committee on Cancer (AJCC) staging 7th edition
  • Fine-needle aspiration (FNA) or core biopsy confirmed axillary nodal metastases at presentation
  • Oestrogen receptor, progesterone receptor and HER2 status evaluated on primary tumour
  • Received standard NACT as per local guidelines
  • Ultrasound of the axilla at completion of NACT
  • Undergo dual tracer sentinel node biopsy after NACT and at least 3 nodes removed (sentinel nodes and marked node). If axillary node sampling is performed following failed localisation of sentinel nodes, patient will be eligible if at least 3 nodes removed (including the marked node).
  • No nodal metastases post NACT (isolated tumour cells, micro or macrometastasis)

Exclusion Criteria:

  • Bilateral invasive breast cancer
  • Sentinel node biopsy prior to NACT
  • Marked node not removed except where the node/s removed show

    • evidence of downstaging with complete pathological response e.g. fibrosis or scarring
  • Previous axillary surgery on the same body side as the scheduled targeted sampling
  • Radiation therapy for the currently diagnosed breast cancer prior to randomisation
  • Previous cancer within 5 years or concomitant malignancy except

    • basal or squamous cell carcinoma of the skin
    • in situ carcinoma of the cervix
    • in situ melanoma
    • contra- or ipsilateral in situ breast cancer

Sites / Locations

  • Airedale NHS Foundation TrustRecruiting
  • North Cumbria Integrated Care NHS Foundation TrustRecruiting
  • Frimley Health NHS Foundation TrustRecruiting
  • NHS HighlandRecruiting
  • James Paget University Hospitals NHS Foundation TrustRecruiting
  • Royal Berkshire NHS Foundation TrustRecruiting
  • East Cheshire NHS TrustRecruiting
  • The Shrewsbury and Telford Hospitals NHS TrustRecruiting
  • NHS GrampianRecruiting
  • Ashford and St Peter's Hospitals NHS Foundation TrustRecruiting
  • Tameside and Glossop Integrated Care NHS Foundation TrustRecruiting
  • NHS Ayrshire and ArranRecruiting
  • University Hospitals Birmingham NHS Foundation TrustRecruiting
  • Sandwell and West Birmingham NHS TrustRecruiting
  • Bolton NHS Foundation TrustRecruiting
  • Bradford Teaching Hospitals NHS Foundation TrustRecruiting
  • North Bristol NHS TrustRecruiting
  • East Lancashire Hospitals NHS TrustRecruiting
  • Cambridge University Hospitals NHS Foundation TrustRecruiting
  • Countess of Chester Hospital NHS TrustRecruiting
  • Mid Cheshire NHS Foundation TrustRecruiting
  • County Durham and Darlington NHS Foundation TrustRecruiting
  • University Hospitals of Derby and Burton NHS Foundation TrustRecruiting
  • NHS Dumfries and GallowayRecruiting
  • NHS FifeRecruiting
  • NHS LanarkshireRecruiting
  • NHS LothianRecruiting
  • Royal Devon and Exeter NHS Foundation TrustRecruiting
  • Gateshead Health NHS Foundation TrustRecruiting
  • Wye Valley NHS TrustRecruiting
  • Buckinghamshire Healthcare NHS TrustRecruiting
  • Calderdale and Huddersfield NHS Foundation TrustRecruiting
  • Hull University Teaching Hospitals NHS TrustRecruiting
  • University Hospitals of Morecambe Bay NHS Foundation TrustRecruiting
  • NHS Forth ValleyRecruiting
  • Leeds Teaching Hospitals NHS TrustRecruiting
  • University Hospitals of Leicester NHS TrustRecruiting
  • United Lincolnshire Hospitals NHS Trust
  • Hywel Dda University Health BoardRecruiting
  • North Middlesex University Hospital NHS TrustRecruiting
  • University College London Hospitals NHS Foundation Trust
  • Royal Free London NHS Foundation TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • The Royal Marsden NHS Foundation TrustRecruiting
  • Imperial College Healthcare NHS TrustRecruiting
  • Bedfordshire Hospitals NHS Foundation TrustRecruiting
  • Manchester University NHS Foundation TrustRecruiting
  • NHS BordersRecruiting
  • South Tees Hospitals NHS Foundation TrustRecruiting
  • Milton Keynes University Hospital NHS TrustRecruiting
  • Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Oxford University Hospitals NHS Foundation TrustRecruiting
  • NHS Greater Glasgow and ClydeRecruiting
  • University Hospitals Plymouth NHS TrustRecruiting
  • St Helens and Knowsley Teaching Hospitals NHS TrustRecruiting
  • The Rotherham NHS Foundation TrustRecruiting
  • West Hertfordshire Hospitals NHS TrustRecruiting
  • North Tees and Hartlepool NHS Foundation TrustRecruiting
  • University Hospitals of North Midlands NHS TrustRecruiting
  • Somerset NHS Foundation TrustRecruiting
  • Royal Cornwall Hospitals NHS TrustRecruiting
  • Mid Yorkshire Hospitals NHS TrustRecruiting
  • Mid and South Essex NHS Foundation TrustRecruiting
  • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation TrustRecruiting
  • Clatterbridge Cancer Centre NHS Foundation TrustRecruiting
  • Wirral University Teaching Hospital NHS Foundation TrustRecruiting
  • The Royal Wolverhampton NHS TrustRecruiting
  • Yeovil District Hospital NHS TrustRecruiting
  • York and Scarborough Teaching Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No axillary treatment

Axillary treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Health related quality of life: EQ-5D-5L
Health related quality of life will be assessed with EQ-5D-5L
Axillary recurrence free interval
Axillary recurrence free interval, calculated from the date of randomisation to the date of axillary recurrence or the censor date.
Overall survival
Overall survival calculated as the time from randomisation until the date of death by any cause or the censor date.
Local (breast or chest wall) recurrence
Number of participants with local (breast or chest wall) recurrence
Regional (nodal) recurrence
Number of participants with regional (nodal) recurrence
Distant metastasis
Number of participants with distant metastasis.
Contralateral breast cancer
Number of participants with contralateral breast cancer.
Non-breast cancer
Number of participants with non-breast cancer

Full Information

First Posted
September 27, 2019
Last Updated
July 18, 2023
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04109079
Brief Title
Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
Acronym
ATNEC
Official Title
ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
February 28, 2030 (Anticipated)
Study Completion Date
February 28, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sentinel Lymph Node, Neoplasm, Breast
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No axillary treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Axillary treatment
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive axillary treatment. Axillary treatment can be axillary lymph node dissection or axillary radiotherapy.
Intervention Type
Procedure
Intervention Name(s)
Axillary lymph node dissection
Intervention Description
Participants will undergo removal of at least level I and II axillary lymph nodes.
Intervention Type
Radiation
Intervention Name(s)
Axillary radiotherapy
Intervention Description
Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Intervention Type
Radiation
Intervention Name(s)
Breast or chest wall radiotherapy
Intervention Description
Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
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.
Time Frame
5 years
Title
Patient reported lymphoedema
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Arm function
Description
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.
Time Frame
5 years
Title
Health related quality of life: EQ-5D-5L
Description
Health related quality of life will be assessed with EQ-5D-5L
Time Frame
5 years
Title
Axillary recurrence free interval
Description
Axillary recurrence free interval, calculated from the date of randomisation to the date of axillary recurrence or the censor date.
Time Frame
5 years
Title
Overall survival
Description
Overall survival calculated as the time from randomisation until the date of death by any cause or the censor date.
Time Frame
5 years
Title
Local (breast or chest wall) recurrence
Description
Number of participants with local (breast or chest wall) recurrence
Time Frame
5 years
Title
Regional (nodal) recurrence
Description
Number of participants with regional (nodal) recurrence
Time Frame
5 years
Title
Distant metastasis
Description
Number of participants with distant metastasis.
Time Frame
5 years
Title
Contralateral breast cancer
Description
Number of participants with contralateral breast cancer.
Time Frame
5 years
Title
Non-breast cancer
Description
Number of participants with non-breast cancer
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cT1-3N1M0 breast cancer at diagnosis (prior to NACT) by American Joint Committee on Cancer (AJCC) staging 8th edition Fine-needle aspiration (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 to assess response to NACT (as per local guidelines) Undergo dual tracer sentinel node biopsy (SNB) after NACT and at least 3 nodes removed in total (sentinel nodes and marked node). If single tracer is used, the patient will be eligible if the involved node is marked before or during NACT, and the marked node and at least 3 nodes (including the marked node) are removed during sentinel node biopsy. If axillary node sampling is performed following failed localisation of sentinel nodes, patient will be eligible if at least 3 nodes removed (including the marked node). If node is not marked, or marked node is not removed, the patient will be eligible 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 if: a) involved node was marked and removed during SNB; and b) removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring. No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis) Exclusion Criteria: Bilateral synchronous invasive breast cancer Sentinel node biopsy prior to NACT Previous axillary surgery on the same body side as the scheduled targeted sampling Any previous cancer within 5 years or concomitant malignancy except basal or squamous cell carcinoma of the skin in situ carcinoma of the cervix in situ melanoma contra- or ipsilateral in situ breast cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Goyal, MS, MD, FRCS
Phone
+44 1332785538
Email
amit.goyal@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Goyal, MS, MD, FRCS
Organizational Affiliation
Royal Derby Hospital, Derby, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Airedale NHS Foundation Trust
City
Keighley
State/Province
Bd20 6td
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Murphy
Facility Name
North Cumbria Integrated Care NHS Foundation Trust
City
Carlisle
State/Province
Ca2 7hy
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludger Barthelmes
Facility Name
Frimley Health NHS Foundation Trust
City
Camberley
State/Province
Gu16 7uj
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiyumars Contractor
First Name & Middle Initial & Last Name & Degree
Hisham Osman
Facility Name
NHS Highland
City
Inverness
State/Province
Iv2 3uj
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Anderson
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
State/Province
Nr31 6la
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Down
Facility Name
Royal Berkshire NHS Foundation Trust
City
Reading
State/Province
Rg1 5an
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Smith
Facility Name
East Cheshire NHS Trust
City
Macclesfield
State/Province
Sk10 3bl.
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jalal Kokan
Facility Name
The Shrewsbury and Telford Hospitals NHS Trust
City
Shrewsbury
State/Province
Sy3 8xq
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Pettit
Facility Name
NHS Grampian
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrix Elsberger
Facility Name
Ashford and St Peter's Hospitals NHS Foundation Trust
City
Ashford
ZIP/Postal Code
TW15 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneliese Lawn
Facility Name
Tameside and Glossop Integrated Care NHS Foundation Trust
City
Ashton-under-Lyne
ZIP/Postal Code
OL6 9RW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pardeep Arora
Facility Name
NHS Ayrshire and Arran
City
Ayr
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graeme Lumsden
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Henderson
Facility Name
Sandwell and West Birmingham NHS Trust
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Hoar
Facility Name
Bolton NHS Foundation Trust
City
Bolton
ZIP/Postal Code
BL4 0JR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Pardo-Garcia
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Linforth
Facility Name
North Bristol NHS Trust
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasirekha Govindarajulu
Facility Name
East Lancashire Hospitals NHS Trust
City
Burnley
ZIP/Postal Code
BB10 2PQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inder Kumar
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Benson
Facility Name
Countess of Chester Hospital NHS Trust
City
Chester
ZIP/Postal Code
CH2 1HJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Hargreaves
Facility Name
Mid Cheshire NHS Foundation Trust
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Hignett
Facility Name
County Durham and Darlington NHS Foundation Trust
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjana Masinghe
Facility Name
University Hospitals of Derby and Burton NHS Foundation Trust
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuele Garreffa
Facility Name
NHS Dumfries and Galloway
City
Dumfries
ZIP/Postal Code
DG2 8RX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aisling Hennessy
Facility Name
NHS Fife
City
Dunfermline
ZIP/Postal Code
KY12 0SU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjory Maclennan
Facility Name
NHS Lanarkshire
City
East Kilbride
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tareq Abdullah
Facility Name
NHS Lothian
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Bedi
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Ferguson
Facility Name
Gateshead Health NHS Foundation Trust
City
Gateshead
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Amonkar
Facility Name
Wye Valley NHS Trust
City
Hereford
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaustuv Das
Facility Name
Buckinghamshire Healthcare NHS Trust
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Holford
Facility Name
Calderdale and Huddersfield NHS Foundation Trust
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Werbena Hamilton-Burke
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kartikae Grover
Facility Name
University Hospitals of Morecambe Bay NHS Foundation Trust
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rishi Parmeshwar
Facility Name
NHS Forth Valley
City
Larbert
ZIP/Postal Code
FK5 4WR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subodh Seth
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma MacInnes
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Kaushik
Facility Name
United Lincolnshire Hospitals NHS Trust
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Hywel Dda University Health Board
City
Llanelli
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saira Khawaja
Facility Name
North Middlesex University Hospital NHS Trust
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lai Cheng Yew
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debashis Ghosh
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Garg
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Krupa
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Leff
Facility Name
Bedfordshire Hospitals NHS Foundation Trust
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth James
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anjana Satpathy
Facility Name
NHS Borders
City
Melrose
ZIP/Postal Code
TD6 9BS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Bedi
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brinda Sethugavalar
Facility Name
Milton Keynes University Hospital NHS Trust
City
Milton Keynes
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Taylor
Facility Name
Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henry Cain
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pankaj Roy
Facility Name
NHS Greater Glasgow and Clyde
City
Paisley
ZIP/Postal Code
PA2 9PN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulla Alhasso
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saed Ramzi
Facility Name
St Helens and Knowsley Teaching Hospitals NHS Trust
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Kiernan
Facility Name
The Rotherham NHS Foundation Trust
City
Rotherham
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tahir Masudi
Facility Name
West Hertfordshire Hospitals NHS Trust
City
St Albans
ZIP/Postal Code
AL3 5PN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Min Lai
Facility Name
North Tees and Hartlepool NHS Foundation Trust
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matei Dordea
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sekhar Marla
Facility Name
Somerset NHS Foundation Trust
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoe Goldthorpe
Facility Name
Royal Cornwall Hospitals NHS Trust
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duncan Wheatley
Facility Name
Mid Yorkshire Hospitals NHS Trust
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Glassman
Facility Name
Mid and South Essex NHS Foundation Trust
City
Westcliff-on-Sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Syed
Facility Name
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
City
Wigan
ZIP/Postal Code
WN1 2NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Zacharioudakis
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaveta Mehta
Facility Name
Wirral University Teaching Hospital NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raman Vinayagam
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghavan Vidya
Facility Name
Yeovil District Hospital NHS Trust
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Osborne
Facility Name
York and Scarborough Teaching Hospitals NHS Foundation Trust
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavani Rengabashyam

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://youtu.be/SFAzvkpkM84
Description
Training video for surgeons to remove the marked node during sentinel node biopsy
URL
https://youtu.be/Nq3tmI6l66s
Description
Training video for radiologists to mark the node using black dye tattoo
URL
https://youtu.be/nLA0fYihVOc
Description
Training video for radiologists to mark the node using clip
URL
https://www.youtube.com/watch?v=s5vqST08HYE
Description
ATNEC breast cancer study - Research Nurse and Patient Consultation
URL
https://www.youtube.com/watch?v=0zAl4PkJV-w&t=4s
Description
ATNEC breast cancer study - Example Doctor and Patient Consultation

Learn more about this trial

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

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