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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adjuvant therapy
Axillary treatment
Sponsored by
University Hospitals of Derby and Burton NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, sentinel lymph node biopsy, axillary lymph node clearance, axillary lymph node dissection, macrometastases, axillary radiotherapy, POSNOC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Adelaide Hospital
  • Bankstown-Lidcocombe Hospital
  • Maeter Hospital
  • Coffs Harbour Health Campus
  • Monash Cancer Centre
  • Royal Melbourne and Royal Women's Hospital
  • Sir Charles Gairdner Hospital
  • Riverina Cancer Care Centre
  • Waikato Hospital
  • Rotorua Hospital
  • Ashford and St Peter's Hospitals NHS Foundation Trust
  • Barnsley Hospital
  • Belfast City Hospital
  • City Hospital
  • Queen Elizabeth Hospital
  • Royal Bolton Hospital
  • Bradford Royal Infirmary
  • Princess of Wales Hospital
  • Addenbrooke's Hospital
  • University Hospital Llandough
  • Darrent Valley Hospital
  • Royal Derby Hospital
  • Eastbourne District General Hospital
  • Western General Hospital
  • Medway Maritime Hospital
  • Western Infirmary
  • Inverclyde Royal Hospital
  • Harrogate District Hospital
  • University Hospital Crosshouse
  • Forth Valley Hospital
  • St James's University Hospital
  • University Hospitals of Leicester NHS Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • Royal Marsden Hospital
  • Luton and Dunstable University Hospital
  • Macclesfield District General Hospital
  • Maidstone Hospital
  • North Manchester General Hospital
  • Wythenshawe Hospital
  • Royal Victoria Infirmary
  • Royal Gwent Hospital
  • The Norfolk and Norwich University Hospital
  • Oxford University Hospitals
  • Peterborough City Hospital
  • Derriford Hospital
  • Rotherham General Hospital
  • Royal Stoke University Hospital
  • Royal Cornwall Hospital
  • Wishaw General Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjuvant therapy alone

Adjuvant therapy plus axillary treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2015
Last Updated
February 13, 2023
Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborators
University of Nottingham, Sussex Health Outcomes Research & Education in Cancer (SHORE-C), NCRI Radiotherapy Trials QA Group (RTTQA), Breast Cancer Trials, Australia and New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT02401685
Brief Title
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
Acronym
POSNOC
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborators
University of Nottingham, Sussex Health Outcomes Research & Education in Cancer (SHORE-C), NCRI Radiotherapy Trials QA Group (RTTQA), Breast Cancer Trials, Australia and New Zealand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, sentinel lymph node biopsy, axillary lymph node clearance, axillary lymph node dissection, macrometastases, axillary radiotherapy, POSNOC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant therapy alone
Arm Type
Experimental
Arm Description
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.
Arm Title
Adjuvant therapy plus axillary treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Adjuvant therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary treatment
Intervention Description
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
Primary Outcome Measure Information:
Title
Axillary recurrence
Description
Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Arm morbidity
Description
Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
Time Frame
3 years
Title
Quality of life
Description
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
Time Frame
3 years
Title
Anxiety (Spielberger State/Trait Anxiety Inventory)
Description
Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
Time Frame
3 years
Title
Economic evaluation (EQ-5D-5L (EuroQoL)
Description
Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
Time Frame
3 years
Title
Local (breast or chest wall) recurrence
Description
Number of participants with local (breast or chest wall) recurrence.
Time Frame
5 years
Title
Regional (nodal) recurrence
Description
Number of participants with regional (nodal) recurrence.
Time Frame
5 years
Title
Distant metastasis
Description
Number of participants with distant metastasis.
Time Frame
5 years
Title
Time to axillary recurrence
Time Frame
5 years
Title
Axillary recurrence free survival
Time Frame
5 years
Title
Disease free survival
Time Frame
5 years
Title
Overall survival
Time Frame
5 years
Title
Contralateral breast cancer
Description
Number of participants with contralateral breast cancer.
Time Frame
5 years
Title
Non-breast malignancy
Description
Number of participants with non-breast malignancy.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Goyal
Organizational Affiliation
University Hospitals of Derby and Burton NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Bankstown-Lidcocombe Hospital
City
Bankstown
Country
Australia
Facility Name
Maeter Hospital
City
Brisbane
Country
Australia
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
Country
Australia
Facility Name
Monash Cancer Centre
City
Melbourne
Country
Australia
Facility Name
Royal Melbourne and Royal Women's Hospital
City
Melbourne
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
Country
Australia
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Rotorua Hospital
City
Rotorua
Country
New Zealand
Facility Name
Ashford and St Peter's Hospitals NHS Foundation Trust
City
Ashford
Country
United Kingdom
Facility Name
Barnsley Hospital
City
Barnsley
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
Country
United Kingdom
Facility Name
City Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Bolton Hospital
City
Bolton
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Facility Name
Princess of Wales Hospital
City
Bridgend
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
University Hospital Llandough
City
Cardiff
Country
United Kingdom
Facility Name
Darrent Valley Hospital
City
Dartford
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
Country
United Kingdom
Facility Name
Inverclyde Royal Hospital
City
Greenock
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
Country
United Kingdom
Facility Name
University Hospital Crosshouse
City
Kilmarnock
Country
United Kingdom
Facility Name
Forth Valley Hospital
City
Larbert
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
Luton and Dunstable University Hospital
City
Luton
Country
United Kingdom
Facility Name
Macclesfield District General Hospital
City
Macclesfield
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport
Country
United Kingdom
Facility Name
The Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
Oxford University Hospitals
City
Oxford
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Rotherham General Hospital
City
Rotherham
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-trent
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26254841
Citation
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.
Results Reference
background
PubMed Identifier
26148870
Citation
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.
Results Reference
background
PubMed Identifier
25245444
Citation
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.
Results Reference
background
Links:
URL
http://www.posnoc.co.uk
Description
Trial website
URL
http://twitter.com/posnoc?lang=en
Description
@POSNOC

Learn more about this trial

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

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