## Protocol Section
### Identification Module
**NCT ID:** NCT04109079

**Acronym:** ATNEC

**Brief Title:** Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

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

#### Organization Study ID Info
**ID:** NIHR 128311
#### Organization
**Class:** OTHER
**Full Name:** University Hospitals of Derby and Burton NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2030-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-31

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2030-02-28

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-26

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2019-09-30
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-27
**Study First Submit QC Date:** 2019-09-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospitals of Derby and Burton NHS Foundation Trust

#### Responsible Party

**Investigator Affiliation:** University Hospitals of Derby and Burton NHS Foundation Trust

**Investigator Full Name:** Dr Amit Goyal

**Investigator Title:** Consultant Oncoplastic Breast Surgeon & Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- 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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1900

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Radiation: Breast or chest wall radiotherapy

**Label:** No axillary treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Procedure: Axillary lymph node dissection

- Radiation: Axillary radiotherapy

- Radiation: Breast or chest wall radiotherapy

**Label:** Axillary treatment

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Axillary treatment

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

**Name:** Axillary lymph node dissection

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Axillary treatment

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

**Name:** Axillary radiotherapy

**Type:** RADIATION

#### Intervention 3

**Arm Group Labels:**

- Axillary treatment

- No axillary treatment

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

**Name:** Breast or chest wall radiotherapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Disease free survival (DFS)

**Time Frame:** 5 years

**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.

**Measure:** Patient reported lymphoedema

**Time Frame:** 5 years

#### Secondary Outcomes

**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.

**Measure:** Arm function

**Time Frame:** 5 years

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

**Measure:** Health related quality of life: EQ-5D-5L

**Time Frame:** 5 years

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

**Measure:** Axillary recurrence free interval

**Time Frame:** 5 years

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

**Measure:** Overall survival

**Time Frame:** 5 years

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

**Measure:** Local (breast or chest wall) recurrence

**Time Frame:** 5 years

**Description:** Number of participants with regional (nodal) recurrence

**Measure:** Regional (nodal) recurrence

**Time Frame:** 5 years

**Description:** Number of participants with distant metastasis.

**Measure:** Distant metastasis

**Time Frame:** 5 years

**Description:** Number of participants with contralateral breast cancer.

**Measure:** Contralateral breast cancer

**Time Frame:** 5 years

**Description:** Number of participants with non-breast cancer

**Measure:** Non-breast cancer

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* cT1-3N1M0 breast cancer at diagnosis (prior to NACT) by American Joint Committee on Cancer (AJCC) staging 8th edition
* Patients with occult primary breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are also eligible for the study.
* 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, 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 in total (sentinel nodes and marked node).
* If a single tracer SNB is performed, the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
* If the node is not marked, or the marked node is not removed, the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
* If fewer than 3 nodes are found on histology, the patient is eligible only if BOTH points a) and b) below, are met:

  1. involved node was marked and removed during SNB; and
  2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed (including the marked node).
* 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.

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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amit.goyal@nhs.net

**Name:** Amit Goyal, MS, MD, FRCS

**Phone:** +44 1332785538

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Keighley

**Contacts:**

***Contact 1:***

- **Name:** Claire Murphy

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Airedale NHS Foundation Trust

**State:** Bd20 6td

**Status:** RECRUITING

**Location 2:**

**City:** Carlisle

**Contacts:**

***Contact 1:***

- **Name:** Ludger Barthelmes

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** North Cumbria Integrated Care NHS Foundation Trust

**State:** Ca2 7hy

**Status:** RECRUITING

**Location 3:**

**City:** Camberley

**Contacts:**

***Contact 1:***

- **Name:** Kaiyumars Contractor

- **Role:** CONTACT

***Contact 2:***

- **Name:** Hisham Osman

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Frimley Health NHS Foundation Trust

**State:** Gu16 7uj

**Status:** RECRUITING

**Location 4:**

**City:** Inverness

**Contacts:**

***Contact 1:***

- **Name:** Eileen Anderson

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Highland

**State:** Iv2 3uj

**Status:** RECRUITING

**Location 5:**

**City:** Great Yarmouth

**Contacts:**

***Contact 1:***

- **Name:** Sue Down

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** James Paget University Hospitals NHS Foundation Trust

**State:** Nr31 6la

**Status:** RECRUITING

**Location 6:**

**City:** Reading

**Contacts:**

***Contact 1:***

- **Name:** Brendan Smith

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Berkshire NHS Foundation Trust

**State:** Rg1 5an

**Status:** RECRUITING

**Location 7:**

**City:** Macclesfield

**Contacts:**

***Contact 1:***

- **Name:** Jalal Kokan

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** East Cheshire NHS Trust

**State:** Sk10 3bl.

**Status:** RECRUITING

**Location 8:**

**City:** Shrewsbury

**Contacts:**

***Contact 1:***

- **Name:** Laura Pettit

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** The Shrewsbury and Telford Hospitals NHS Trust

**State:** Sy3 8xq

**Status:** RECRUITING

**Location 9:**

**City:** Aberdeen

**Contacts:**

***Contact 1:***

- **Name:** Beatrix Elsberger

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Grampian

**Status:** RECRUITING

**Zip:** AB25 2ZN

**Location 10:**

**City:** Ashford

**Contacts:**

***Contact 1:***

- **Name:** Anneliese Lawn

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Ashford and St Peter's Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** TW15 3AA

**Location 11:**

**City:** Ashton-under-Lyne

**Contacts:**

***Contact 1:***

- **Name:** Pardeep Arora

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Tameside and Glossop Integrated Care NHS Foundation Trust

**Status:** RECRUITING

**Zip:** OL6 9RW

**Location 12:**

**City:** Ayr

**Contacts:**

***Contact 1:***

- **Name:** Graeme Lumsden

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Ayrshire and Arran

**Status:** RECRUITING

**Zip:** KA6 6DX

**Location 13:**

**City:** Belfast

**Contacts:**

***Contact 1:***

- **Name:** Gareth Irwin

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Belfast Health and Social Care Trust

**Status:** RECRUITING

**Zip:** BT9 7AB

**Location 14:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Daniel Henderson

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals Birmingham NHS Foundation Trust

**Status:** RECRUITING

**Zip:** B15 2GW

**Location 15:**

**City:** Birmingham

**Contacts:**

***Contact 1:***

- **Name:** Fiona Hoar

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Sandwell and West Birmingham NHS Trust

**Status:** RECRUITING

**Zip:** B18 7QH

**Location 16:**

**City:** Bolton

**Contacts:**

***Contact 1:***

- **Name:** Ricardo Pardo-Garcia

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Bolton NHS Foundation Trust

**Status:** RECRUITING

**Zip:** BL4 0JR

**Location 17:**

**City:** Bradford

**Contacts:**

***Contact 1:***

- **Name:** Richard Linforth

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Bradford Teaching Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** BD5 0NA

**Location 18:**

**City:** Brighton

**Contacts:**

***Contact 1:***

- **Name:** Rathinasabapathy Rathinaezhil

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals Sussex NHS Foundation Trust

**Status:** RECRUITING

**Zip:** BN2 5BE

**Location 19:**

**City:** Bristol

**Contacts:**

***Contact 1:***

- **Name:** Sasirekha Govindarajulu

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** North Bristol NHS Trust

**Status:** RECRUITING

**Zip:** BS10 5NB

**Location 20:**

**City:** Burnley

**Contacts:**

***Contact 1:***

- **Name:** Inder Kumar

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** East Lancashire Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** BB10 2PQ

**Location 21:**

**City:** Cambridge

**Contacts:**

***Contact 1:***

- **Name:** John Benson

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Cambridge University Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** CB2 0QQ

**Location 22:**

**City:** Chester

**Contacts:**

***Contact 1:***

- **Name:** Anita Hargreaves

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Countess of Chester Hospital NHS Trust

**Status:** RECRUITING

**Zip:** CH2 1HJ

**Location 23:**

**City:** Crewe

**Contacts:**

***Contact 1:***

- **Name:** Susan Hignett

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Mid Cheshire NHS Foundation Trust

**Status:** RECRUITING

**Zip:** CW1 4QJ

**Location 24:**

**City:** Darlington

**Contacts:**

***Contact 1:***

- **Name:** Sanjana Masinghe

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** County Durham and Darlington NHS Foundation Trust

**Status:** RECRUITING

**Zip:** DL3 6HX

**Location 25:**

**City:** Derby

**Contacts:**

***Contact 1:***

- **Name:** Emanuele Garreffa

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals of Derby and Burton NHS Foundation Trust

**Status:** RECRUITING

**Zip:** DE22 3NE

**Location 26:**

**City:** Doncaster

**Contacts:**

***Contact 1:***

- **Name:** Lynda Wyld

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** DN2 5LT

**Location 27:**

**City:** Dudley

**Contacts:**

***Contact 1:***

- **Name:** Velin Voynov

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** The Dudley Group NHS Foundation Trust

**Status:** RECRUITING

**Zip:** DY1 2HQ

**Location 28:**

**City:** Dumfries

**Contacts:**

***Contact 1:***

- **Name:** Aisling Hennessy

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Dumfries and Galloway

**Status:** RECRUITING

**Zip:** DG2 8RX

**Location 29:**

**City:** Dunfermline

**Contacts:**

***Contact 1:***

- **Name:** Marjory Maclennan

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Fife

**Status:** RECRUITING

**Zip:** KY12 0SU

**Location 30:**

**City:** East Kilbride

**Contacts:**

***Contact 1:***

- **Name:** Tareq Abdullah

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Lanarkshire

**Status:** RECRUITING

**Zip:** G75 8RG

**Location 31:**

**City:** Edinburgh

**Contacts:**

***Contact 1:***

- **Name:** Carolyn Bedi

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Lothian

**Status:** RECRUITING

**Zip:** EH4 2XU

**Location 32:**

**City:** Exeter

**Contacts:**

***Contact 1:***

- **Name:** Douglas Ferguson

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Devon and Exeter NHS Foundation Trust

**Status:** RECRUITING

**Zip:** EX2 5DW

**Location 33:**

**City:** Gateshead

**Contacts:**

***Contact 1:***

- **Name:** Sunil Amonkar

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Gateshead Health NHS Foundation Trust

**Status:** RECRUITING

**Zip:** NE9 6SX

**Location 34:**

**City:** Harrogate

**Contacts:**

***Contact 1:***

- **Name:** Biswajit Ray

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Harrogate and District NHS Foundation Trust

**Status:** RECRUITING

**Zip:** HG2 7SX

**Location 35:**

**City:** Hereford

**Contacts:**

***Contact 1:***

- **Name:** Kaustuv Das

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Wye Valley NHS Trust

**Status:** RECRUITING

**Zip:** HR1 2ER

**Location 36:**

**City:** High Wycombe

**Contacts:**

***Contact 1:***

- **Name:** Nicholas Holford

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Buckinghamshire Healthcare NHS Trust

**Status:** RECRUITING

**Zip:** HP11 2TT

**Location 37:**

**City:** Huddersfield

**Contacts:**

***Contact 1:***

- **Name:** Werbena Hamilton-Burke

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Calderdale and Huddersfield NHS Foundation Trust

**Status:** RECRUITING

**Zip:** HD3 3EA

**Location 38:**

**City:** Hull

**Contacts:**

***Contact 1:***

- **Name:** Kartikae Grover

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Hull University Teaching Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** HU16 5JQ

**Location 39:**

**City:** Ipswich

**Contacts:**

***Contact 1:***

- **Name:** Hussein Tuffaha

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** East Suffolk and North Essex NHS Foundation Trust

**Status:** RECRUITING

**Zip:** IP4 5PD

**Location 40:**

**City:** Isleworth

**Contacts:**

***Contact 1:***

- **Name:** Musa Barkeji

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Chelsea and Westminster Hospital NHS Foundation Trust

**Status:** RECRUITING

**Zip:** TW7 6AF

**Location 41:**

**City:** Lancaster

**Contacts:**

***Contact 1:***

- **Name:** Rishi Parmeshwar

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals of Morecambe Bay NHS Foundation Trust

**Status:** RECRUITING

**Zip:** LA1 4RP

**Location 42:**

**City:** Larbert

**Contacts:**

***Contact 1:***

- **Name:** Subodh Seth

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Forth Valley

**Status:** RECRUITING

**Zip:** FK5 4WR

**Location 43:**

**City:** Leeds

**Contacts:**

***Contact 1:***

- **Name:** Emma MacInnes

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Leeds Teaching Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** LS9 7TF

**Location 44:**

**City:** Leicester

**Contacts:**

***Contact 1:***

- **Name:** Monika Kaushik

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals of Leicester NHS Trust

**Status:** RECRUITING

**Zip:** LE3 9QP

**Location 45:**

**City:** Lincoln

**Country:** United Kingdom

**Facility:** United Lincolnshire Hospitals NHS Trust

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** LN2 5QY

**Location 46:**

**City:** Llanelli

**Contacts:**

***Contact 1:***

- **Name:** Saira Khawaja

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Hywel Dda University Health Board

**Status:** RECRUITING

**Zip:** SA14 8QF

**Location 47:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Lai Cheng Yew

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** North Middlesex University Hospital NHS Trust

**Status:** RECRUITING

**Zip:** N18 1QX

**Location 48:**

**City:** London

**Country:** United Kingdom

**Facility:** University College London Hospitals NHS Foundation Trust

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** NW1 2BU

**Location 49:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Debashis Ghosh

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Free London NHS Foundation Trust

**Status:** RECRUITING

**Zip:** NW3 2QG

**Location 50:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Neeraj Garg

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** King's College Hospital NHS Foundation Trust

**Status:** RECRUITING

**Zip:** SE5 9RS

**Location 51:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Katherine Krupa

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** The Royal Marsden NHS Foundation Trust

**Status:** RECRUITING

**Zip:** SM2 5PT

**Location 52:**

**City:** London

**Contacts:**

***Contact 1:***

- **Name:** Daniel Leff

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Imperial College Healthcare NHS Trust

**Status:** RECRUITING

**Zip:** W6 8RF

**Location 53:**

**City:** Luton

**Contacts:**

***Contact 1:***

- **Name:** Ruth James

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Bedfordshire Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** LU4 0DZ

**Location 54:**

**City:** Manchester

**Contacts:**

***Contact 1:***

- **Name:** Anjana Satpathy

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Manchester University NHS Foundation Trust

**Status:** RECRUITING

**Zip:** M8 5RB

**Location 55:**

**City:** Melrose

**Contacts:**

***Contact 1:***

- **Name:** Carolyn Bedi

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Borders

**Status:** RECRUITING

**Zip:** TD6 9BS

**Location 56:**

**City:** Middlesbrough

**Contacts:**

***Contact 1:***

- **Name:** Brinda Sethugavalar

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** South Tees Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** TS4 3BW

**Location 57:**

**City:** Milton Keynes

**Contacts:**

***Contact 1:***

- **Name:** Amanda Taylor

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Milton Keynes University Hospital NHS Trust

**Status:** RECRUITING

**Zip:** MK6 5LD

**Location 58:**

**City:** Newcastle Upon Tyne

**Contacts:**

***Contact 1:***

- **Name:** Henry Cain

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Newcastle Upon Tyne Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** NE1 4LP

**Location 59:**

**City:** Oxford

**Contacts:**

***Contact 1:***

- **Name:** Pankaj Roy

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Oxford University Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** OX3 7LE

**Location 60:**

**City:** Paisley

**Contacts:**

***Contact 1:***

- **Name:** Abdulla Alhasso

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** NHS Greater Glasgow and Clyde

**Status:** RECRUITING

**Zip:** PA2 9PN

**Location 61:**

**City:** Plymouth

**Contacts:**

***Contact 1:***

- **Name:** Saed Ramzi

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals Plymouth NHS Trust

**Status:** RECRUITING

**Zip:** PL6 8DH

**Location 62:**

**City:** Prescot

**Contacts:**

***Contact 1:***

- **Name:** Tamara Kiernan

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** St Helens and Knowsley Teaching Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** L35 5DR

**Location 63:**

**City:** Rotherham

**Contacts:**

***Contact 1:***

- **Name:** Tahir Masudi

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** The Rotherham NHS Foundation Trust

**Status:** RECRUITING

**Zip:** S60 2UD

**Location 64:**

**City:** St Albans

**Contacts:**

***Contact 1:***

- **Name:** Lee Min Lai

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** West Hertfordshire Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** AL3 5PN

**Location 65:**

**City:** Stevenage

**Contacts:**

***Contact 1:***

- **Name:** Muhammed Baki

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** East and North Hertfordshire NHS Foundation Trust

**Status:** RECRUITING

**Zip:** SG1 4AB

**Location 66:**

**City:** Stockton-on-Tees

**Contacts:**

***Contact 1:***

- **Name:** Matei Dordea

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** North Tees and Hartlepool NHS Foundation Trust

**Status:** RECRUITING

**Zip:** TS19 8PE

**Location 67:**

**City:** Stoke-on-Trent

**Contacts:**

***Contact 1:***

- **Name:** Sekhar Marla

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** University Hospitals of North Midlands NHS Trust

**Status:** RECRUITING

**Zip:** ST4 6QG

**Location 68:**

**City:** Taunton

**Contacts:**

***Contact 1:***

- **Name:** Zoe Goldthorpe

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Somerset NHS Foundation Trust

**Status:** RECRUITING

**Zip:** TA1 5DA

**Location 69:**

**City:** Thornton Heath

**Contacts:**

***Contact 1:***

- **Name:** Lubna Noor

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Croydon Health Services NHS Trust

**Status:** RECRUITING

**Zip:** CR7 7YE

**Location 70:**

**City:** Truro

**Contacts:**

***Contact 1:***

- **Name:** Duncan Wheatley

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Cornwall Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** TR1 3LJ

**Location 71:**

**City:** Wakefield

**Contacts:**

***Contact 1:***

- **Name:** Daniel Glassman

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Mid Yorkshire Hospitals NHS Trust

**Status:** RECRUITING

**Zip:** WF1 4DG

**Location 72:**

**City:** Westcliff-on-Sea

**Contacts:**

***Contact 1:***

- **Name:** Abdul Syed

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Mid and South Essex NHS Foundation Trust

**Status:** RECRUITING

**Zip:** SS0 0RY

**Location 73:**

**City:** Wigan

**Contacts:**

***Contact 1:***

- **Name:** Konstantinos Zacharioudakis

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** WN1 2NN

**Location 74:**

**City:** Wirral

**Contacts:**

***Contact 1:***

- **Name:** Shaveta Mehta

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Clatterbridge Cancer Centre NHS Foundation Trust

**Status:** RECRUITING

**Zip:** CH63 4JY

**Location 75:**

**City:** Wirral

**Contacts:**

***Contact 1:***

- **Name:** Raman Vinayagam

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Wirral University Teaching Hospital NHS Foundation Trust

**Status:** RECRUITING

**Zip:** CH63 4JY

**Location 76:**

**City:** Wolverhampton

**Contacts:**

***Contact 1:***

- **Name:** Raghavan Vidya

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** The Royal Wolverhampton NHS Trust

**Status:** RECRUITING

**Zip:** WV10 0QP

**Location 77:**

**City:** Yeovil

**Contacts:**

***Contact 1:***

- **Name:** Caroline Osborne

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Yeovil District Hospital NHS Trust

**Status:** RECRUITING

**Zip:** BA21 4AT

**Location 78:**

**City:** York

**Contacts:**

***Contact 1:***

- **Name:** Bhavani Rengabashyam

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** York and Scarborough Teaching Hospitals NHS Foundation Trust

**Status:** RECRUITING

**Zip:** YO31 8HE

#### Overall Officials

**Official 1:**

**Affiliation:** Royal Derby Hospital, Derby, UK

**Name:** Amit Goyal, MS, MD, FRCS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Training video for surgeons to remove the marked node during sentinel node biopsy

**URL:** https://youtu.be/SFAzvkpkM84

**Label:** Training video for radiologists to mark the node using black dye tattoo

**URL:** https://youtu.be/Nq3tmI6l66s

**Label:** Training video for radiologists to mark the node using clip

**URL:** https://youtu.be/nLA0fYihVOc

**Label:** ATNEC breast cancer study - Research Nurse and Patient Consultation

**URL:** https://www.youtube.com/watch?v=s5vqST08HYE

**Label:** ATNEC breast cancer study - Example Doctor and Patient Consultation

**URL:** https://www.youtube.com/watch?v=0zAl4PkJV-w&t=4s

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
