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ACTIVE NOT RECRUITING
NCT02401685
NA

POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

View on ClinicalTrials.gov

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

OTHER

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.

PROCEDURE

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