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Breast CancerPOSNOCNCT02401685

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

A study testing Adjuvant therapy and Axillary treatment in people with Breast Cancer, run by University Hospitals of Derby and Burton NHS Foundation Trust at 50 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Adjuvant therapy and Axillary treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,900 participants
Where
50 sitesin 3 countries
Study dates
1 Aug 2014to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

50 sites in 3 countries.

50 sites in 3 countries

United Kingdom40 sites

  • Ashford and St Peter's Hospitals NHS Foundation Trust

    Ashford

  • Barnsley Hospital

    Barnsley

  • Belfast City Hospital

    Belfast

  • City Hospital

    Birmingham

  • Queen Elizabeth Hospital

    Birmingham

  • Royal Bolton Hospital

    Bolton

  • Bradford Royal Infirmary

    Bradford

  • Princess of Wales Hospital

    Bridgend

  • Addenbrooke's Hospital

    Cambridge

  • University Hospital Llandough

    Cardiff

  • Darrent Valley Hospital

    Dartford

  • Royal Derby Hospital

    Derby

  • Eastbourne District General Hospital

    Eastbourne

  • Western General Hospital

    Edinburgh

  • Medway Maritime Hospital

    Gillingham

  • Western Infirmary

    Glasgow

  • Inverclyde Royal Hospital

    Greenock

  • Harrogate District Hospital

    Harrogate

  • University Hospital Crosshouse

    Kilmarnock

  • Forth Valley Hospital

    Larbert

  • St James's University Hospital

    Leeds

  • University Hospitals of Leicester NHS Trust

    Leicester

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • Royal Marsden Hospital

    London

  • Luton and Dunstable University Hospital

    Luton

  • Macclesfield District General Hospital

    Macclesfield

  • Maidstone Hospital

    Maidstone

  • North Manchester General Hospital

    Manchester

  • Wythenshawe Hospital

    Manchester

  • Royal Victoria Infirmary

    Newcastle upon Tyne

  • Royal Gwent Hospital

    Newport

  • The Norfolk and Norwich University Hospital

    Norwich

  • Oxford University Hospitals

    Oxford

  • Peterborough City Hospital

    Peterborough

  • Derriford Hospital

    Plymouth

  • Rotherham General Hospital

    Rotherham

  • Royal Stoke University Hospital

    Stoke-on-Trent

  • Royal Cornwall Hospital

    Truro

  • Wishaw General Hospital

    Wishaw

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide

  • Bankstown-Lidcocombe Hospital

    Bankstown

  • Maeter Hospital

    Brisbane

  • Coffs Harbour Health Campus

    Coffs Harbour

  • Monash Cancer Centre

    Melbourne

  • Royal Melbourne and Royal Women's Hospital

    Melbourne

  • Sir Charles Gairdner Hospital

    Perth

  • Riverina Cancer Care Centre

    Wagga Wagga

Other trials in Australia

New Zealand2 sites

  • Waikato Hospital

    Hamilton

  • Rotorua Hospital

    Rotorua

Other trials in New Zealand

About this study

Official 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

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.

Read more

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.

Conditions
Breast Cancer
Being tested
Adjuvant therapy, Axillary treatment
Keywords
breast cancer, sentinel lymph node biopsy, axillary lymph node clearance, axillary lymph node dissection, macrometastases, axillary radiotherapy, POSNOC
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvant therapyOther

    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.

  • Axillary treatmentProcedure or surgery

    Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.

Study groups in NCT02401685
Study groupRoleWhat they receive
Adjuvant therapy aloneExperimentalWomen 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.
Receives: Other: Adjuvant therapy
Adjuvant therapy plus axillary treatmentActive comparatorWomen 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.
Receives: Other: Adjuvant therapy; Procedure: Axillary treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Axillary recurrence

    Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.

    Measured: 5 years

Secondary outcomes (13)

  1. Arm morbidity

    Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.

    Measured: 3 years

  2. Quality of life

    Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.

    Measured: 3 years

  3. Anxiety (Spielberger State/Trait Anxiety Inventory)

    Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.

    Measured: 3 years

  4. Economic evaluation (EQ-5D-5L (EuroQoL)

    Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.

    Measured: 3 years

  5. Local (breast or chest wall) recurrence

    Number of participants with local (breast or chest wall) recurrence.

    Measured: 5 years

  6. Regional (nodal) recurrence

    Number of participants with regional (nodal) recurrence.

    Measured: 5 years

  7. Distant metastasis

    Number of participants with distant metastasis.

    Measured: 5 years

  8. Time to axillary recurrence

    Measured: 5 years

  9. Axillary recurrence free survival

    Measured: 5 years

  10. Disease free survival

    Measured: 5 years

  11. Overall survival

    Measured: 5 years

  12. Contralateral breast cancer

    Number of participants with contralateral breast cancer.

    Measured: 5 years

  13. Non-breast malignancy

    Number of participants with non-breast malignancy.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study start1 Aug 2014
  3. Primary completionJul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02401685
Sponsor's protocol ID
RD-5103-001-13
Other IDs
ISRCTN Number
Acronym
POSNOC
Status last verified
Jul 2025
First submitted
11 Mar 2015
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 26254841

  • 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.

    PubMed 26148870

  • 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.

    PubMed 25245444

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvant therapy and Axillary treatment in people with Breast Cancer, run by University Hospitals of Derby and Burton NHS Foundation Trust at 50 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Axillary recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401685, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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