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NCT Number: NCT02401685

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvant therapy

Other

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 treatment

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Quality of life

    Time frame: 3 years

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

  3. Anxiety (Spielberger State/Trait Anxiety Inventory)

    Time frame: 3 years

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

  4. 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.

  5. Local (breast or chest wall) recurrence

    Time frame: 5 years

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

  6. Regional (nodal) recurrence

    Time frame: 5 years

    Number of participants with regional (nodal) recurrence.

  7. Distant metastasis

    Time frame: 5 years

    Number of participants with distant metastasis.

  8. Time to axillary recurrence

    Time frame: 5 years

  9. Axillary recurrence free survival

    Time frame: 5 years

  10. Disease free survival

    Time frame: 5 years

  11. Overall survival

    Time frame: 5 years

  12. Contralateral breast cancer

    Time frame: 5 years

    Number of participants with contralateral breast cancer.

  13. Non-breast malignancy

    Time frame: 5 years

    Number of participants with non-breast malignancy.

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Collaborators

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

Registry information

Official study 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

Acronym: POSNOC

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2015
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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