POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
POSNOC
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
2 other identifiers
interventional
1,900
3 countries
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2014
Longer than P75 for not_applicable breast-cancer
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 10, 2025
July 1, 2025
11.9 years
March 11, 2015
July 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
5 years
Secondary Outcomes (13)
Arm morbidity
3 years
Quality of life
3 years
Anxiety (Spielberger State/Trait Anxiety Inventory)
3 years
Economic evaluation (EQ-5D-5L (EuroQoL)
3 years
Local (breast or chest wall) recurrence
5 years
- +8 more secondary outcomes
Study Arms (2)
Adjuvant therapy alone
EXPERIMENTALWomen 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 plus axillary treatment
ACTIVE COMPARATORWomen 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.
Interventions
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 can be axillary node clearance or axillary radiotherapy as per local guidelines.
Eligibility Criteria
You may qualify if:
- Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
- 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
You may not qualify if:
- bilateral invasive breast cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (3)
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.
PMID: 26254841BACKGROUNDDodwell 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.
PMID: 26148870BACKGROUNDGoyal 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.
PMID: 25245444BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Goyal
University Hospitals of Derby and Burton NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Oncoplastic Breast Surgeon & Associate Professor
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 30, 2015
Study Start
August 1, 2014
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 10, 2025
Record last verified: 2025-07