Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
Recruiting · NCT04109079 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
Axillary lymph node dissectionAxillary radiotherapyBreast or chest wall radiotherapy
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
- 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:
- involved node was marked and removed during SNB; and
- removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
- If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed.
- No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)
- Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study
- Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed.
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
Where it is running
60 locations listed.
- Aberdeen Royal Infirmary - NHS Grampian - Aberdeen, United Kingdom
- Ashford Hospital - Ashford and St Peter's Hospitals NHS Foundation Trust - Ashford, United Kingdom
- Tameside General Hospital- Tameside and Glossop Integrated Care NHS Foundation Trust - Ashton-under-Lyne, United Kingdom
- University Hospital Crosshouse - NHS Ayrshire and Arran - Ayr, United Kingdom
- Basildon University Hospital - Mid and South Essex NHS Foundation Trust - Basildon, United Kingdom
- Belfast City Hospital - Belfast Health and Social Care Trust - Belfast, United Kingdom
- QEHB- University Hospitals Birmingham NHS Foundation Trust - Birmingham, United Kingdom
- City Hospital -Sandwell and West Birmingham NHS Trust - Birmingham, United Kingdom
- Blackpool Victoria Hospital - Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool, United Kingdom
- Royal Bolton Hospital - Bolton NHS Foundation Trust - Bolton, United Kingdom
- St Luke's Hospital - Bradford Teaching Hospitals NHS Foundation Trust - Bradford, United Kingdom
- Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust - Brighton, United Kingdom
- Southmead Hospital - North Bristol NHS Trust - Bristol, United Kingdom
- Burnley General Hospital- East Lancashire Hospitals NHS Trust - Burnley, United Kingdom
- Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust - Cambridge, United Kingdom
- Cheltenham General Hospital - Gloucestershire General Hospitals NHS Foundation Trust - Cheltenham, United Kingdom
- Countess of Chester Hospital - Countess of Chester Hospital NHS Trust - Chester, United Kingdom
- Leighton Hospital - Mid Cheshire NHS Foundation Trust - Crewe, United Kingdom
- Darlington Memorial Hospital - County Durham and Darlington NHS Foundation Trust - Darlington, United Kingdom
- Royal Derby Hospital- University Hospitals of Derby and Burton NHS Foundation Trust - Derby, United Kingdom
- Doncaster Royal Infirmary - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust - Doncaster, United Kingdom
- St Vincent's University Hospital - St Vincent's Healthcare Group - Dublin, Ireland
- St Luke's Hospital - St Luke's Radiation Oncology Network - Dublin, Ireland
- Beaumont Hospital - Royal College of Surgeons in Ireland - Dublin, Ireland
- Russell's Hall Hospital - The Dudley Group NHS Foundation Trust - Dudley, United Kingdom
- Dumfries and Galloway Royal Infirmary - NHS Dumfries and Galloway - Dumfries, United Kingdom
- Queen Margert Hospital - NHS Fife - Dunfermline, United Kingdom
- University Hospital Hairmyres - NHS Lanarkshire - East Kilbride, United Kingdom
- Western General Hospital -NHS Lothian - Edinburgh, United Kingdom
- Royal Devon & Exeter Hospital - Royal Devon and Exeter NHS Foundation Trust - Exeter, United Kingdom
- Galway University Hospitals - Saolta University Health Care Group - Galway, Ireland
- Queen Elizabeth Hospital - Gateshead Health NHS Foundation Trust - Gateshead, United Kingdom
- Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board - Glasgow, United Kingdom
- Royal Surrey County Hospital - Royal Surrey NHS Foundation Trust - Guildford, United Kingdom
- Harrogate District Hospital - Harrogate and District NHS Foundation Trust - Harrogate, United Kingdom
- Hereford County Hospital- Wye Valley NHS Trust - Hereford, United Kingdom
- Wycombe Hospital - Buckinghamshire Healthcare NHS Trust - High Wycombe, United Kingdom
- Huddersfield Royal Infirmary- Calderdale and Huddersfield NHS Foundation Trust - Huddersfield, United Kingdom
- Castle Hill Hospital - Hull University Teaching Hospitals NHS Trust - Hull, United Kingdom
- Ipswich Hospital - East Suffolk and North Essex NHS Foundation Trust - Ipswich, United Kingdom
- West Middlesex University Hospital - Chelsea and Westminster Hospital NHS Foundation Trust - Isleworth, United Kingdom
- Royal Lancaster Infirmary - University Hospitals of Morecambe Bay NHS Foundation Trust - Lancaster, United Kingdom
- Forth Valley Royal Hospital - NHS Forth Valley - Larbert, United Kingdom
- St James's University Hospital - Leeds Teaching Hospitals NHS Trust - Leeds, United Kingdom
- Glenfield Hospital - University Hospitals of Leicester NHS Trust - Leicester, United Kingdom
- Lincoln County Hospital - United Lincolnshire Hospitals NHS Trust - Lincoln, United Kingdom
- Prince Phillip Hospital -Hywel Dda University Health Board - Llanelli, United Kingdom
- North Middlesex University Hospital - North Middlesex University Hospital NHS Trust - London, United Kingdom
- The Whittington Hospital - Whittington Health NHS Trust - London, United Kingdom
- UCL Hospital - University College London Hospitals NHS Foundation Trust - London, United Kingdom
- Royal Free Hospital - Royal Free London NHS Foundation Trust - London, United Kingdom
- Kings College Hospital - King's College Hospital NHS Foundation Trust - London, United Kingdom
- The Royal Marsden NHS Foundation Trust - London, United Kingdom
- Charing Cross Hospital -Imperial College Healthcare NHS Trust - London, United Kingdom
- Luton and Dunstable Hospital -Bedfordshire Hospitals NHS Foundation Trust - Luton, United Kingdom
- Wythenshawe Hospital - Manchester University Hospital NHS Foundation Trust - Manchester, United Kingdom
- North Manchester General -Manchester University NHS Foundation Trust - Manchester, United Kingdom
- Borders General Hospital -NHS Borders - Melrose, United Kingdom
- Clatterbridge Cancer Centre - The Clatterbridge Cancer Centre NHS Foundation Trust - Metropolitan Borough of Wirral, United Kingdom
- Clatterbridge Hospital - Wirral University Teaching Hospital NHS Foundation Trust - Metropolitan Borough of Wirral, United Kingdom
Showing 60 of 98 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →