Clinical trial NCT02401685: POSNOC - A Trial Looking at Axillary Treatment in Early Breast Cancer
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
sentinel lymph node biopsy
axillary lymph node clearance
axillary lymph node dissection
macrometastases
axillary radiotherapy
POSNOC
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
name: NCRI Radiotherapy Trials QA Group (RTTQA)
name: Breast Cancer Trials, Australia and New Zealand
First posted: 2015-03-30
Enrollment: 1900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Axillary recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Arm morbidity
timeFrame: 3 years
measure: Quality of life
timeFrame: 3 years
measure: Anxiety (Spielberger State/Trait Anxiety Inventory)
timeFrame: 3 years
measure: Economic evaluation (EQ-5D-5L (EuroQoL)
timeFrame: 3 years
measure: Local (breast or chest wall) recurrence
timeFrame: 5 years
measure: Regional (nodal) recurrence
timeFrame: 5 years
measure: Distant metastasis
timeFrame: 5 years
measure: Time to axillary recurrence
timeFrame: 5 years
measure: Axillary recurrence free survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Contralateral breast cancer
timeFrame: 5 years
measure: Non-breast malignancy
timeFrame: 5 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Bankstown
country: Australia
facility: Bankstown-Lidcocombe Hospital
city: Brisbane
country: Australia
facility: Maeter Hospital
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
city: Melbourne
country: Australia
facility: Monash Cancer Centre
city: Melbourne
country: Australia
facility: Royal Melbourne and Royal Women's Hospital
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: Wagga Wagga
country: Australia
facility: Riverina Cancer Care Centre
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Rotorua
country: New Zealand
facility: Rotorua Hospital
city: Ashford
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Foundation Trust
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: City Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Bridgend
country: United Kingdom
facility: Princess of Wales Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Llandough
city: Dartford
country: United Kingdom
facility: Darrent Valley Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Glasgow
country: United Kingdom
facility: Western Infirmary
city: Greenock
country: United Kingdom
facility: Inverclyde Royal Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
city: Kilmarnock
country: United Kingdom
facility: University Hospital Crosshouse
city: Larbert
country: United Kingdom
facility: Forth Valley Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Luton
country: United Kingdom
facility: Luton and Dunstable University Hospital
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
city: Norwich
country: United Kingdom
facility: The Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Rotherham
country: United Kingdom
facility: Rotherham General Hospital
city: Stoke-on-trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: University Hospitals of Derby and Burton NHS Foundation Trust
name: Amit Goyal
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.