TADPOLE v1.0
Research type
Research Study
Full title
Targeted Axillary Dissection versus axillary node clearance in patients with Positive axillary Lymph nodes in Early breast cancer: A multicentre, pragmatic, phase III randomised controlled trial
IRAS ID
333212
Contact name
Shelley Potter
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
7 years, 6 months, 31 days
Research summary
Breast cancer affects 55,000 patients each year in the UK, and in ~20% of cases, the cancer will have spread to the armpit (axillary) lymph nodes. The current standard treatment for these patients is to remove all the axillary lymph nodes (axillary node clearance), even if only one or two are affected. However, one in three patients will experience life changing complications as a result of this treatment, including permanent swelling of the arm (lymphoedema), long-term pain, and problems with shoulder function. These complications dramatically affect quality of life and are costly to the NHS.
Axillary node clearance (ANC) was believed to give patients the best chance of surviving their breast cancer, but there is no evidence to show that this is true if the spread to the axillary lymph nodes is limited. More targeted surgery to the armpit, called a targeted axillary dissection (TAD), in which just the lymph nodes containing cancer and the first draining (sentinel) lymph nodes are removed may be just as safe and reduce the risk of life-changing complications.The TADPOLE study aims to determine whether targeted armpit surgery (TAD) reduces the risk of lymphoedema at 12 months after the operation without increasing the risk of the cancer returning, compared to ANC.
861 patients will be recruited from 40 UK NHS Breast Units. One group will receive ANC (standard care), while the other group will receive TAD. Patients will be assigned to a group by randomisation to ensure that the groups are similar.
TADPOLE will compare how many patients have lymphoedema 12 months after surgery, and patients will be followed up for five years to ensure that the risk of the cancer returning after receiving TAD is acceptable. We will also collect information on surgical complications, shoulder function, pain, quality of life and financial costs.
REC name
Wales REC 3
REC reference
25/WA/0139
Date of REC Opinion
13 May 2025
REC opinion
Favourable Opinion