Condition category
Cancer
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
10/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Amit Goyal

ORCID ID

Contact details

Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
+44 (0)1332 785538
amit.goyal@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16069 RD-5103-001-13

Study information

Scientific title

POSNOC - POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes

Acronym

POSNOC

Study hypothesis

The hypothesis of the POSNOC trial is that low axillary tumour burden patients (clinically and ultrasound node negative) with macrometastases in 1 or 2 sentinel nodes, receiving systemic therapy, would have non-inferior outcomes whether they are randomised to adjuvant therapy alone or adjuvant therapy plus axillary treatment (axillary node clearance or axillary radiotherapy).

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=16069

Ethics approval

Nottingham Research Ethics Committee 2, 13/EM/0459, First REC approval date 02/01/2014

Study design

Pragmatic randomised multi-centre non-inferiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast Cancer

Intervention

The trial interventions are either:
1. Adjuvant therapy alone (intervention)
Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to this group.

2. Adjuvant therapy plus axillary treatment (standard care)
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.

All participants will have adjuvant therapy according to local guidelines. 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Axillary recurrence; Timepoint(s): at 5 years

Secondary outcome measures

1. Anxiety; Timepoint(s): assessed at 3, 6, 12, 24, 36 months
2. Arm morbidity; Timepoint(s): assessed at 3, 6, 12, 24 and 36 months
3. Axillary recurrence free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
4. Contralateral breast cancer; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
5. Disease free survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
6. Distant metastasis; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
7. Economic evaluation; Timepoint(s): assessed at 3, 6, 12, 24, 36 months
8. Local (breast or chest wall) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
9. Non-breast malignancy; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
10. Overall survival; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
11. Quality of life; Timepoint(s): assessed at 3, 6, 12, 24, 36 months
12. Regional (nodal) recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months
13. Time to axillary recurrence; Timepoint(s): assessed at 6, 12, 24, 36, 48 and 60 months

Overall trial start date

01/01/2014

Overall trial end date

31/12/2023

Reason abandoned

Eligibility

Participant inclusion criteria

Women will be eligible for inclusion only if ALL of the following criteria apply:
1. 18 years or older
2. Unifocal or multifocal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or for women who are randomised intraoperatively
largest tumour diameter on mammogram or ultrasound.
3. No axillary nodal metastasis on clinical and ultrasound examination.
4. At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
5. Fit for axillary treatment and adjuvant therapy.
6. Have given written informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1900

Participant exclusion criteria

Women will be excluded if they have:
1. Bilateral breast cancer
2. More than 2 sentinel node macrometastases or extranodal invasion
3. Neoadjuvant therapy for breast cancer
4. Previous axillary surgery on the same body side as the scheduled sentinel node biopsy
5. Not fit or eligible to receive adjuvant systemic therapy
6. Previous or concomitant malignancy except
6.1. adequately treated basal or squamous cell carcinoma of the skin or
6.2. adequately treated in situ carcinoma of the cervix or
6.3. adequately treated in situ melanoma
6.4. contra- or ipsilateral in situ breast cancer

Recruitment start date

01/01/2014

Recruitment end date

31/12/2023

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Derby Hospital
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Derby Hospital NHS Foundation Trust (UK)

Sponsor details

Dr Teresa M. Grieve
Assistant Director of Research & Development
Research & Development Department
Royal Derby Hospital
Derby
DE22 3DT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes