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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02401685




Registration number
NCT02401685
Ethics application status
Date submitted
11/03/2015
Date registered
30/03/2015
Date last updated
11/02/2019

Titles & IDs
Public title
POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
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
Secondary ID [1] 0 0
ISRCTN Number
Secondary ID [2] 0 0
RD-5103-001-13
Universal Trial Number (UTN)
Trial acronym
POSNOC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Adjuvant therapy
Treatment: Surgery - Axillary 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.

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 interventions: 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.

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Axillary recurrence - Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Arm morbidity - Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Quality of life - Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Anxiety (Spielberger State/Trait Anxiety Inventory) - Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Economic evaluation (EQ-5D-5L (EuroQoL) - Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Local (breast or chest wall) recurrence - Number of participants with local (breast or chest wall) recurrence.
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Regional (nodal) recurrence - Number of participants with regional (nodal) recurrence.
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Distant metastasis - Number of participants with distant metastasis.
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Time to axillary recurrence
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Axillary recurrence free survival
Timepoint [9] 0 0
5 years
Secondary outcome [10] 0 0
Disease free survival
Timepoint [10] 0 0
5 years
Secondary outcome [11] 0 0
Overall survival
Timepoint [11] 0 0
5 years
Secondary outcome [12] 0 0
Contralateral breast cancer - Number of participants with contralateral breast cancer.
Timepoint [12] 0 0
5 years
Secondary outcome [13] 0 0
Non-breast malignancy - Number of participants with non-breast malignancy.
Timepoint [13] 0 0
5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Bankstown-Lidcocombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Maeter Hospital - Brisbane
Recruitment hospital [4] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [5] 0 0
Monash Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Royal Melbourne and Royal Women's Hospital - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [8] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bankstown
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Coffs Harbour
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Wagga Wagga
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton
Country [2] 0 0
New Zealand
State/province [2] 0 0
Rotorua
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Ashford
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Barnsley
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Belfast
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Birmingham
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Bolton
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Bradford
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Bridgend
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cambridge
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Cardiff
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Dartford
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Derby
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Eastbourne
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Edinburgh
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Gillingham
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Glasgow
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Greenock
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Harrogate
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Kilmarnock
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Larbert
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Leeds
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Leicester
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Luton
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Macclesfield
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Maidstone
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Manchester
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Newcastle upon Tyne
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Newport
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Norwich
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Oxford
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Peterborough
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Plymouth
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Rotherham
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Stoke-on-trent
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Truro
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Wishaw
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
Derby Hospitals NHS Foundation Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Nottingham
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
NCRI Radiotherapy Trials QA Group (RTTQA)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Breast Cancer Trials, Australia and New Zealand
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02401685
Trial related presentations / 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Amit Goyal
Address 0 0
Derby Hospitals NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amit Goyal
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
amit.goyal@nhs.net
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02401685