POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, sentinel lymph node biopsy, axillary lymph node clearance, axillary lymph node dissection, macrometastases, axillary radiotherapy, POSNOC
Eligibility Criteria
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
Sites / Locations
- Royal Adelaide Hospital
- Bankstown-Lidcocombe Hospital
- Maeter Hospital
- Coffs Harbour Health Campus
- Monash Cancer Centre
- Royal Melbourne and Royal Women's Hospital
- Sir Charles Gairdner Hospital
- Riverina Cancer Care Centre
- Waikato Hospital
- Rotorua Hospital
- Ashford and St Peter's Hospitals NHS Foundation Trust
- Barnsley Hospital
- Belfast City Hospital
- City Hospital
- Queen Elizabeth Hospital
- Royal Bolton Hospital
- Bradford Royal Infirmary
- Princess of Wales Hospital
- Addenbrooke's Hospital
- University Hospital Llandough
- Darrent Valley Hospital
- Royal Derby Hospital
- Eastbourne District General Hospital
- Western General Hospital
- Medway Maritime Hospital
- Western Infirmary
- Inverclyde Royal Hospital
- Harrogate District Hospital
- University Hospital Crosshouse
- Forth Valley Hospital
- St James's University Hospital
- University Hospitals of Leicester NHS Trust
- Guy's and St Thomas' NHS Foundation Trust
- Royal Marsden Hospital
- Luton and Dunstable University Hospital
- Macclesfield District General Hospital
- Maidstone Hospital
- North Manchester General Hospital
- Wythenshawe Hospital
- Royal Victoria Infirmary
- Royal Gwent Hospital
- The Norfolk and Norwich University Hospital
- Oxford University Hospitals
- Peterborough City Hospital
- Derriford Hospital
- Rotherham General Hospital
- Royal Stoke University Hospital
- Royal Cornwall Hospital
- Wishaw General Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Adjuvant therapy alone
Adjuvant therapy plus axillary treatment
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.
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.