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Clinical Trials in Ireland / NCT04109079
Recruiting Not applicable

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

NCT04109079 · tracked via the Priya Life Science Ireland tracker
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Phase
Not applicable
Started
2021-02-26
Last updated
2026-03-30

Condition(s) studied

Breast CancerSentinel Lymph NodeNeoplasm, Breast

Investigational drug(s) / intervention(s)

Axillary lymph node dissectionAxillary radiotherapyBreast or chest wall radiotherapy

Axillary lymph node dissection: Participants will undergo removal of at least level I and II axillary lymph nodes.

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 * 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: 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. * 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

Primary outcome measure(s)

Trial sites (98)

FacilityCityRegionStatus
St Vincent's University Hospital - St Vincent's Healthcare Group Dublin Ireland Recruiting
St Luke's Hospital - St Luke's Radiation Oncology Network Dublin Ireland Recruiting
Beaumont Hospital - Royal College of Surgeons in Ireland Dublin Ireland Recruiting
Galway University Hospitals - Saolta University Health Care Group Galway Ireland Recruiting
Airedale General Hospital - Airedale NHS Foundation Trust Keighley BD20 6TD Recruiting
Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust Carlisle CA2 7HY Recruiting
Frimley Park Hospital - Frimley Health NHS Foundation Trust Camberley GU16 7UJ Recruiting
Raigmore Hospital - NHS Highland Inverness IV2 3UJ Recruiting
James Paget Hospital -James Paget University Hospitals NHS Foundation Trust Great Yarmouth NR31 6LA Recruiting
Royal Berkshire Hospital - Royal Berkshire NHS Foundation Trust Reading RG1 5AN Recruiting
Macclesfield District General Hospital - East Cheshire NHS Trust Macclesfield SK10 3BL. Recruiting
Royal Shrewsbury Hospital -The Shrewsbury and Telford Hospitals NHS Trust Shrewsbury SY3 8XQ Recruiting
Aberdeen Royal Infirmary - NHS Grampian Aberdeen United Kingdom Recruiting
Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust Ashford United Kingdom Recruiting
Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust Ashton-under-Lyne United Kingdom Recruiting
University Hospital Crosshouse - NHS Ayrshire and Arran Ayr United Kingdom Recruiting
Basildon University Hospital - Mid and South Essex NHS Foundation Trust Basildon United Kingdom Recruiting
Belfast City Hospital - Belfast Health and Social Care Trust Belfast United Kingdom Recruiting
QEHB- University Hospitals Birmingham NHS Foundation Trust Birmingham United Kingdom Recruiting
City Hospital -Sandwell and West Birmingham NHS Trust Birmingham United Kingdom Recruiting
Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust Blackpool United Kingdom Recruiting
Royal Bolton Hospital - Bolton NHS Foundation Trust Bolton United Kingdom Recruiting
St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust Bradford United Kingdom Recruiting
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust Brighton United Kingdom Recruiting
Southmead Hospital - North Bristol NHS Trust Bristol United Kingdom Recruiting
Burnley General Hospital- East Lancashire Hospitals NHS Trust Burnley United Kingdom Recruiting
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom Recruiting
Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust Cheltenham United Kingdom Recruiting
Countess of Chester Hospital - Countess of Chester Hospital NHS Trust Chester United Kingdom Recruiting
Leighton Hospital - Mid Cheshire NHS Foundation Trust Crewe United Kingdom Recruiting
Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust Darlington United Kingdom Recruiting
Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust Derby United Kingdom Recruiting
Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust Doncaster United Kingdom Recruiting
Russell's Hall Hospital - The Dudley Group NHS Foundation Trust Dudley United Kingdom Recruiting
Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway Dumfries United Kingdom Recruiting
Queen Margert Hospital - NHS Fife Dunfermline United Kingdom Active Not Recruiting
University Hospital Hairmyres - NHS Lanarkshire East Kilbride United Kingdom Recruiting
Western General Hospital -NHS Lothian Edinburgh United Kingdom Recruiting
Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust Exeter United Kingdom Recruiting
Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust Gateshead United Kingdom Recruiting

+ 58 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04109079 on ClinicalTrials.gov ↗ ← All trials in Ireland