POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer | Recruiting
POSNOC - A Trial Looking at Axillar... | Recruiting
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
POSNOC

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Medical Conditions
  • Breast Cancer
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02401685
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Other : Adjuvant therapy, Procedure : Axillary treatment

Study Arm Groups : Adjuvant therapy alone, Adjuvant therapy plus axillary treatment, Adjuvant therapy plus axillary treatment

Intervention Type
See Interventions above
Primary Outcome Measures
    Axillary recurrence; 5 years
Secondary Outcome Measures
    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; Regional (nodal) recurrence; 5 years; Distant metastasis; 5 years; Time to axillary recurrence; 5 years; Axillary recurrence free survival; 5 years; Disease free survival; 5 years; Overall survival; 5 years; Contralateral breast cancer; 5 years; Non-breast malignancy; 5 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
1900
Participant Inclusion Criteria
    Inclusion Criteria:

    - Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (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 sentinel 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 breast cancer

    - more than 2 nodes with macrometastases

    - neoadjuvant therapy for breast cancer

    - 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

    - adequately treated basal or squamous cell carcinoma of the skin

    - adequately treated in situ carcinoma of the cervix

    - adequately treated in situ melanoma

    - contra- or ipsilateral in situ breast cancer
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Cambridge
Cambridgeshire
Local Institution
Glasgow
Central
Local Institution
Plymouth
Devon
Local Institution
London
Greater London
Local Institution
Oxford
Oxfordshire
Manchester
Belfast
Edinburgh
Queen Elizabeth Hospital
Birmingham
Cardiff
Newcastle upon Tyne
Stonehill Medical Center
Bolton
Leeds
Truro
Cornwall
Norfolk and Norwich University Hospital
Norwich
Uni Hospital Leicester
Leicester
Uni Hospital North Staffordshire
Stoke-on-Trent
Derby
Bradford Royal Infirmary
Bradford
NHS Forth Valley Hospital
Larbert
Crosshouse Hospital
Kilmarnock
Darent Valley Hospital
Dartford
Medway Maritime Hospital
Gillingham
Harrogate District Hospital
Harrogate
Luton and Dunstable Hospital
Luton
Maidstone Hospital and The Tunbridge Wells Hospital
Maidstone
Local Institution
Newport
Gwent
1182.58.44011 Boehringer Ingelheim Investigational Site
Peterborough
Research Site
Wolverhampton
Investigative site
Eastbourne
Wishaw General Hospital
Wishaw
Barnsley
Nycomed Investigational Site
Ashford
Middlesex
Research Site
Macclesfield
Cheshire
Research Site
Rotherham
Bridgend
NHS Greater Glasgow & Clyde
Greenock
Inverclyde
Trial Contact(s)
Primary Trial Contact
Amit Goyal
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, New Zealand, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
  • University of Nottingham
  • Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
  • NCRI Radiotherapy Trials QA Group (RTTQA)
Other Study ID Numbers
RD-5103-001-13
Sponsor(s)
Derby Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

Jan 2014

Recruitment End Date

Mar 2023

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

11 Mar 2015

Date updated in source

20 Aug 2016