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Spots Global Cancer Trial Database for POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Amit Goyal

Affiliation: University Hospitals of Derby and Burton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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