Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy (ATNEC)
Breast Cancer, Sentinel Lymph Node, Neoplasm, Breast
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
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
Experimental
Active Comparator
No axillary treatment
Axillary treatment
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.