Closed & in Follow up

POSNOC

Overview

POSNOC - POsitive Sentinel Node: Observation versus Clearance or radiotherapy: A randomised controlled trial of axillary treatment in patients with early stage breast cancer who have metastases in one or two sentinel nodes.

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

Objectives

Primary outcome measure

The primary outcome is axillary recurrence at 5 years.

Secondary outcome measures

Secondary outcomes assessed at 3, 6, 12, 24 and 36 months are:

Arm morbidity
Quality of life
Anxiety
Economic outcomes

Secondary outcomes assessed at 6, 12, 24, 36, 48 and 60 months are:

Local (breast or chest wall) recurrence
Regional (nodal) recurrence
Distant metastasis
Time to axillary recurrence
Axillary recurrence free survival
Disease free survival
Overall survival
Contralateral breast cancer
Non-breast malignancy

Inclusion/ exclusion criteria

Inclusion criteria

Women will be eligible for inclusion only if ALL of the following criteria apply:

18 years or older
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 neoadjuvanttherapy (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 macrometastases on molecular assay)
Fit for axillary treatment and adjuvant therapy
Have given written informed consent

Exclusion criteria

bilateral breast cancer
more than 2 nodes with macrometastases
neoadjuvant therapy for breast cancer
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