POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
NCT ID: NCT02401685
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1900 participants
INTERVENTIONAL
2014-08-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adjuvant therapy alone
Women in this arm will have adjuvant therapy but no treatment to their armpit after surgery. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to this arm.
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.
Adjuvant therapy plus axillary treatment
Women in this arm will have adjuvant therapy plus treatment to their armpit after surgery. Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay)
* Fit for axillary treatment and adjuvant therapy
* Have given written informed consent
Exclusion Criteria
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer except:
* if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer
* short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months)
* previous axillary surgery on the same body side as the scheduled sentinel node biopsy
* not receiving adjuvant systemic therapy
* previous cancer less than 5 years previously 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
18 Years
FEMALE
No
Sponsors
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University of Nottingham
OTHER
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
UNKNOWN
NCRI Radiotherapy Trials QA Group (RTTQA)
UNKNOWN
Breast Cancer Trials, Australia and New Zealand
OTHER
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Dr Amit Goyal
Consultant Oncoplastic Breast Surgeon & Associate Professor
Principal Investigators
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Amit Goyal
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Derby and Burton NHS Foundation Trust
Locations
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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
Countries
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References
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Goyal A, Dodwell D. POSNOC: A Randomised Trial Looking at Axillary Treatment in Women with One or Two Sentinel Nodes with Macrometastases. Clin Oncol (R Coll Radiol). 2015 Dec;27(12):692-5. doi: 10.1016/j.clon.2015.07.005. Epub 2015 Aug 5. No abstract available.
Dodwell D, Goyal A. Axillary conservation in early breast cancer. Br J Surg. 2015 Oct;102(11):1297-9. doi: 10.1002/bjs.9881. Epub 2015 Jul 7. No abstract available.
Goyal A, Dodwell D, Reed MW, Coleman RE. Axillary treatment in women with one or two sentinel nodes with macrometastases: more evidence is needed to inform practice. J Clin Oncol. 2014 Dec 1;32(34):3902. doi: 10.1200/JCO.2014.57.3717. Epub 2014 Sep 22. No abstract available.
Related Links
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Trial website
X/twitter account
Other Identifiers
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ISRCTN Number
Identifier Type: REGISTRY
Identifier Source: secondary_id
RD-5103-001-13
Identifier Type: -
Identifier Source: org_study_id
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