Breast Cancer Clinical Trial
— POSNOCOfficial 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
| Verified date | February 2024 |
| Source | University Hospitals of Derby and Burton NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1900 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | July 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | 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 | |
| New Zealand | Waikato Hospital | Hamilton | |
| New Zealand | Rotorua Hospital | Rotorua | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | Breast Cancer Trials, Australia and New Zealand, NCRI Radiotherapy Trials QA Group (RTTQA), Sussex Health Outcomes Research & Education in Cancer (SHORE-C), University of Nottingham |
Australia, New Zealand, United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Axillary recurrence | Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site. | 5 years | |
| Secondary | Arm morbidity | Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires. | 3 years | |
| Secondary | Quality of life | Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire. | 3 years | |
| Secondary | Anxiety (Spielberger State/Trait Anxiety Inventory) | Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory. | 3 years | |
| Secondary | Economic evaluation (EQ-5D-5L (EuroQoL) | Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument. | 3 years | |
| Secondary | Local (breast or chest wall) recurrence | Number of participants with local (breast or chest wall) recurrence. | 5 years | |
| Secondary | Regional (nodal) recurrence | Number of participants with regional (nodal) recurrence. | 5 years | |
| Secondary | Distant metastasis | Number of participants with distant metastasis. | 5 years | |
| Secondary | Time to axillary recurrence | 5 years | ||
| Secondary | Axillary recurrence free survival | 5 years | ||
| Secondary | Disease free survival | 5 years | ||
| Secondary | Overall survival | 5 years | ||
| Secondary | Contralateral breast cancer | Number of participants with contralateral breast cancer. | 5 years | |
| Secondary | Non-breast malignancy | Number of participants with non-breast malignancy. | 5 years |
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