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 their breast cancer also have the first one or two lymph glands (sentinel nodes) in their armpit (axilla) removed, a 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 may no longer be needed. Axillary treatment is associatged with lymphoedema and other long term complications such as numbness, pain and shoulder stiffness. These problems can be upsetting and difficult to cope with.
This trial aims to assess whether adjuvant therapy alone is no worse than (non-inferior to) adjuant 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. Sites in Australia and New Zealand will open to recruitment from February 2016.
Contact: Shabina Sadiq
Funding: NIHR Health Technology Assessment
Further Information: Email Shabina Sadiq (Trial Manager) email@example.com