POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: Adjuvant therapyProcedure: Axillary treatment
- Registration Number
- NCT02401685
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 1900
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant therapy alone Adjuvant therapy 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 plus axillary treatment Adjuvant therapy 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 plus axillary treatment 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.
- Primary Outcome Measures
Name Time Method Axillary recurrence 5 years Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
- Secondary Outcome Measures
Name Time Method Anxiety (Spielberger State/Trait Anxiety Inventory) 3 years Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
Economic evaluation (EQ-5D-5L (EuroQoL) 3 years Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
Distant metastasis 5 years Number of participants with distant metastasis.
Disease free survival 5 years Overall survival 5 years Arm morbidity 3 years Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
Local (breast or chest wall) recurrence 5 years Number of participants with local (breast or chest wall) recurrence.
Regional (nodal) recurrence 5 years Number of participants with regional (nodal) recurrence.
Axillary recurrence free survival 5 years Contralateral breast cancer 5 years Number of participants with contralateral breast cancer.
Non-breast malignancy 5 years Number of participants with non-breast malignancy.
Quality of life 3 years Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
Time to axillary recurrence 5 years
Trial Locations
- Locations (50)
Monash Cancer Centre
🇦🇺Melbourne, Australia
Waikato Hospital
🇳🇿Hamilton, New Zealand
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Rotorua Hospital
🇳🇿Rotorua, New Zealand
Riverina Cancer Care Centre
🇦🇺Wagga Wagga, Australia
Royal Melbourne and Royal Women's Hospital
🇦🇺Melbourne, Australia
Barnsley Hospital
🇬🇧Barnsley, United Kingdom
Bankstown-Lidcocombe Hospital
🇦🇺Bankstown, Australia
Coffs Harbour Health Campus
🇦🇺Coffs Harbour, Australia
Sir Charles Gairdner Hospital
🇦🇺Perth, Australia
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
Maeter Hospital
🇦🇺Brisbane, Australia
Darrent Valley Hospital
🇬🇧Dartford, United Kingdom
Princess of Wales Hospital
🇬🇧Bridgend, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust
🇬🇧Ashford, United Kingdom
City Hospital
🇬🇧Birmingham, United Kingdom
Western Infirmary
🇬🇧Glasgow, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
University Hospital Llandough
🇬🇧Cardiff, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
Inverclyde Royal Hospital
🇬🇧Greenock, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, United Kingdom
Forth Valley Hospital
🇬🇧Larbert, United Kingdom
Royal Marsden Hospital
🇬🇧London, United Kingdom
University Hospital Crosshouse
🇬🇧Kilmarnock, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Luton and Dunstable University Hospital
🇬🇧Luton, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Peterborough City Hospital
🇬🇧Peterborough, United Kingdom
Royal Gwent Hospital
🇬🇧Newport, United Kingdom
The Norfolk and Norwich University Hospital
🇬🇧Norwich, 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
Royal Bolton Hospital
🇬🇧Bolton, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Oxford University Hospitals
🇬🇧Oxford, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom