Information for professionals
This page gives a brief overview for clinicians and research staff. It does not replace the protocol, Investigator Site File or sponsor documentation.
Study summary
- Design: Multicentre pragmatic phase III randomised controlled trial with an internal pilot, embedded qualitative work, surgical and radiotherapy QA, and a recruitment SWAT.
- Population: Adults with unilateral early breast cancer and low-volume axillary nodal disease (≤2 nodes involved on ultrasound, biopsy-proven), undergoing primary surgery.
- Interventions: Targeted axillary dissection (TAD) versus axillary node clearance (ANC), 2:1 randomisation.
- Co-primary outcomes: Lymphoedema at 12 months and locoregional recurrence at 5 years.
Key documents
Official documents are provided via the sponsor and Bristol Trials Centre. Please refer to your local R&D department and the Investigator Site File for the latest versions.
- Protocol and amendments
- Investigator Site File and working documents
- Patient-facing materials (PILs, consent forms, questionnaires)
- Surgical and radiotherapy QA guidance
- Data collection and reporting procedures