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Brief Title: POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
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
Study ID: NCT02401685
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Amit Goyal
Affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR