Trial name: POsitive Sentinel NOde: Adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy. A randomised controlled trial in women with early stage breast cancer (POSNOC)
Chief Investigator: Amit Goyal, Derby Teaching Hospitals NHS Foundation Trust
Trial description: Each year over 48,000 women are diagnosed with brest cancer in the UK. Currently women having surgical treatment for early breast cancer also have the first one or two lymph glands (sentinel nodes) in their armpit (axilla) removed, an early procedure called sentinel node biopsy. For about a quarter of women, the breast cancer has spread to these sentinel nodes. Currently, these women are offered axillary treatment. This is either a second operation to remove all the axillary lymph glands (axillary node clearance) or axillary radiotherapy. The women also received adjuvant therapy (chemotherapy, hormone therapy, radiotherapy or breast of chest wall). Outcome is now very good following adjuvant therapy, and so routine axillary treatment which has unavoidable adverse effects may no longer be needed. Axillary treatment is associated with lymphoedema and other long term complications such as numbness, pain and shoulder stiffness. These arm problems can be upsetting and difficult to cope with and are often irreversible.
Trial aim: This trial aims to assess whether adjuvant therapy alone is no worse than (non-inferior to) adjuvant therapy plus axillary treatment for women with early stage breast cancer who have macrometastases in one or two axillary lymph nodes. The primary outcome is axillary recurrence within 5 years. The planned sample size is 1900 women. Recruitment began in the UK in July 2014, and extended to Australia and New Zealand in 2016. 1597 randomisations were achieved by the end of 2019. Recruitment will continue until July 2021, and primary outcome collection is due to finish in 2026.
Contact: Shabina Sadiq
Funding: NIHR Health Technology Assessment, National Health and Medical Research Council (Australia)
Further Information: Email Shabina Sadiq (Trial Manager) firstname.lastname@example.org