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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02401685
Registration number
NCT02401685
Ethics application status
Date submitted
11/03/2015
Date registered
30/03/2015
Date last updated
20/02/2024
Titles & IDs
Public title
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
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Scientific 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
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Secondary ID [1]
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ISRCTN Number
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Secondary ID [2]
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RD-5103-001-13
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Universal Trial Number (UTN)
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Trial acronym
POSNOC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Adjuvant therapy
Treatment: Surgery - Axillary treatment
Experimental: 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.
Active comparator: 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.
Other interventions: 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.
Treatment: Surgery: Axillary treatment
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Axillary recurrence
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Assessment method [1]
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Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Arm morbidity
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Assessment method [1]
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Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Quality of life
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Assessment method [2]
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Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Anxiety (Spielberger State/Trait Anxiety Inventory)
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Assessment method [3]
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Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Economic evaluation (EQ-5D-5L (EuroQoL)
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Assessment method [4]
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Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
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Timepoint [4]
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3 years
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Secondary outcome [5]
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Local (breast or chest wall) recurrence
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Assessment method [5]
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Number of participants with local (breast or chest wall) recurrence.
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Timepoint [5]
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5 years
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Secondary outcome [6]
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Regional (nodal) recurrence
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Assessment method [6]
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Number of participants with regional (nodal) recurrence.
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Timepoint [6]
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5 years
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Secondary outcome [7]
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Distant metastasis
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Assessment method [7]
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Number of participants with distant metastasis.
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Timepoint [7]
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5 years
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Secondary outcome [8]
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Time to axillary recurrence
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Assessment method [8]
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Timepoint [8]
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5 years
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Secondary outcome [9]
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Axillary recurrence free survival
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Assessment method [9]
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Timepoint [9]
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5 years
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Secondary outcome [10]
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Disease free survival
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Assessment method [10]
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Timepoint [10]
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5 years
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Secondary outcome [11]
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Overall survival
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Assessment method [11]
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Timepoint [11]
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5 years
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Secondary outcome [12]
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Contralateral breast cancer
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Assessment method [12]
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Number of participants with contralateral breast cancer.
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Timepoint [12]
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5 years
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Secondary outcome [13]
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Non-breast malignancy
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Assessment method [13]
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Number of participants with non-breast malignancy.
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Timepoint [13]
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5 years
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
1900
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Bankstown-Lidcocombe Hospital - Bankstown
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Maeter Hospital - Brisbane
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Coffs Harbour Health Campus - Coffs Harbour
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Monash Cancer Centre - Melbourne
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Royal Melbourne and Royal Women's Hospital - Melbourne
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Perth
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Recruitment hospital [8]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Bankstown
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- Brisbane
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- Coffs Harbour
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- Melbourne
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Recruitment postcode(s) [6]
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- Perth
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Recruitment postcode(s) [7]
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- Wagga Wagga
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Recruitment outside Australia
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New Zealand
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Hamilton
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New Zealand
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Rotorua
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United Kingdom
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Ashford
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United Kingdom
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Barnsley
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Belfast
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Birmingham
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Bolton
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Bradford
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Bridgend
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Cambridge
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Cardiff
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Dartford
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Derby
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Eastbourne
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Edinburgh
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Gillingham
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Glasgow
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Greenock
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Harrogate
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Kilmarnock
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Larbert
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Leeds
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Leicester
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Luton
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Macclesfield
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Maidstone
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Manchester
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Newcastle upon Tyne
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Newport
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Norwich
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Oxford
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Peterborough
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Plymouth
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Rotherham
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Truro
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Wishaw
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospitals of Derby and Burton NHS Foundation Trust
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Address
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Other collaborator category [1]
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Other
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University of Nottingham
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Other
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Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
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Other
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NCRI Radiotherapy Trials QA Group (RTTQA)
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Other
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Name [4]
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Breast Cancer Trials, Australia and New Zealand
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02401685
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Amit Goyal
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Address
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University Hospitals of Derby and Burton NHS Foundation Trust
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02401685
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