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POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Summary
POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial. Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years. Stratification: Institution, Age (\<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no). Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)). Sample Size: 1900 participants Follow-up: Participants will be followed up for 5 years. Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.
Official title: POSNOC - POsitive Sentinel NOde: Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance or Axillary Radiotherapy. A Randomised Controlled Trial of Axillary Treatment in Women With Early Stage Breast Cancer Who Have Metastases in One or Two Sentinel Nodes
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1900
Start Date
2014-08-01
Completion Date
2026-12-31
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
Adjuvant therapy
Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may also be administered when indicated.
Axillary treatment
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
Locations (50)
Royal Adelaide Hospital
Adelaide, Australia
Bankstown-Lidcocombe Hospital
Bankstown, Australia
Maeter Hospital
Brisbane, Australia
Coffs Harbour Health Campus
Coffs Harbour, Australia
Monash Cancer Centre
Melbourne, Australia
Royal Melbourne and Royal Women's Hospital
Melbourne, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Riverina Cancer Care Centre
Wagga Wagga, Australia
Waikato Hospital
Hamilton, New Zealand
Rotorua Hospital
Rotorua, New Zealand
Ashford and St Peter's Hospitals NHS Foundation Trust
Ashford, United Kingdom
Barnsley Hospital
Barnsley, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
City Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Princess of Wales Hospital
Bridgend, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
University Hospital Llandough
Cardiff, United Kingdom
Darrent Valley Hospital
Dartford, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Western Infirmary
Glasgow, United Kingdom
Inverclyde Royal Hospital
Greenock, United Kingdom
Harrogate District Hospital
Harrogate, United Kingdom
University Hospital Crosshouse
Kilmarnock, United Kingdom
Forth Valley Hospital
Larbert, United Kingdom
St James's University Hospital
Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom
Macclesfield District General Hospital
Macclesfield, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
The Norfolk and Norwich University Hospital
Norwich, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Rotherham General Hospital
Rotherham, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Wishaw General Hospital
Wishaw, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom