POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer (POSNOC)

February 15, 2024 updated by: Dr Amit Goyal, University Hospitals of Derby and Burton NHS Foundation Trust

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Bankstown, Australia
        • Bankstown-Lidcocombe Hospital
      • Brisbane, Australia
        • Maeter Hospital
      • Coffs Harbour, Australia
        • Coffs Harbour Health Campus
      • Melbourne, Australia
        • Monash Cancer Centre
      • Melbourne, Australia
        • Royal Melbourne and Royal Women's Hospital
      • Perth, Australia
        • Sir Charles Gairdner Hospital
      • Wagga Wagga, Australia
        • Riverina Cancer Care Centre
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital
      • Rotorua, New Zealand
        • Rotorua Hospital
  • United Kingdom
      • Ashford, United Kingdom
        • Ashford and St Peter's Hospitals NHS Foundation Trust
      • Barnsley, United Kingdom
        • Barnsley Hospital
      • Belfast, United Kingdom
        • Belfast City Hospital
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom
        • City Hospital
      • Bolton, United Kingdom
        • Royal Bolton Hospital
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Bridgend, United Kingdom
        • Princess of Wales Hospital
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Cardiff, United Kingdom
        • University Hospital Llandough
      • Dartford, United Kingdom
        • Darrent Valley Hospital
      • Derby, United Kingdom
        • Royal Derby Hospital
      • Eastbourne, United Kingdom
        • Eastbourne District General Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • Gillingham, United Kingdom
        • Medway Maritime Hospital
      • Glasgow, United Kingdom
        • Western Infirmary
      • Greenock, United Kingdom
        • Inverclyde Royal Hospital
      • Harrogate, United Kingdom
        • Harrogate District Hospital
      • Kilmarnock, United Kingdom
        • University Hospital Crosshouse
      • Larbert, United Kingdom
        • Forth Valley Hospital
      • Leeds, United Kingdom
        • St James's University Hospital
      • Leicester, United Kingdom
        • University Hospitals Of Leicester Nhs Trust
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom
        • Royal Marsden Hospital
      • Luton, United Kingdom
        • Luton and Dunstable University Hospital
      • Macclesfield, United Kingdom
        • Macclesfield District General Hospital
      • Maidstone, United Kingdom
        • Maidstone Hospital
      • Manchester, United Kingdom
        • Wythenshawe Hospital
      • Manchester, United Kingdom
        • North Manchester General Hospital
      • Newcastle upon Tyne, United Kingdom
        • Royal Victoria Infirmary
      • Newport, United Kingdom
        • Royal Gwent Hospital
      • Norwich, United Kingdom
        • The Norfolk and Norwich University Hospital
      • Oxford, United Kingdom
        • Oxford University Hospitals
      • Peterborough, United Kingdom
        • Peterborough City Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Rotherham, United Kingdom
        • Rotherham General Hospital
      • Stoke-on-trent, United Kingdom
        • Royal Stoke University Hospital
      • Truro, United Kingdom
        • Royal Cornwall Hospital
      • Wishaw, United Kingdom
        • Wishaw General Hospital
      • Wolverhampton, United Kingdom
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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.
Other: 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.
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: 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.
Procedure: Axillary treatment
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary recurrence
Time Frame: 5 years
Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Disease free survival
Time Frame: 5 years
5 years
Distant metastasis
Time Frame: 5 years
Number of participants with distant metastasis.
5 years
Contralateral breast cancer
Time Frame: 5 years
Number of participants with contralateral breast cancer.
5 years
Arm morbidity
Time Frame: 3 years
Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
3 years
Quality of life
Time Frame: 3 years
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
3 years
Anxiety (Spielberger State/Trait Anxiety Inventory)
Time Frame: 3 years
Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
3 years
Economic evaluation (EQ-5D-5L (EuroQoL)
Time Frame: 3 years
Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
3 years
Local (breast or chest wall) recurrence
Time Frame: 5 years
Number of participants with local (breast or chest wall) recurrence.
5 years
Regional (nodal) recurrence
Time Frame: 5 years
Number of participants with regional (nodal) recurrence.
5 years
Time to axillary recurrence
Time Frame: 5 years
5 years
Axillary recurrence free survival
Time Frame: 5 years
5 years
Non-breast malignancy
Time Frame: 5 years
Number of participants with non-breast malignancy.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborators

University of Nottingham
Breast Cancer Trials, Australia and New Zealand
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
NCRI Radiotherapy Trials QA Group (RTTQA)

Investigators

  • Principal Investigator: Amit Goyal, University Hospitals of Derby and Burton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 11, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimated)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD-5103-001-13
  • ISRCTN Number (Registry Identifier: ISRCTN54765244)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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