BACKGROUND

Breast cancer affects 55,000 patients each year. In ~20% of them, the cancer will have spread to the armpit (axillary) lymph nodes at diagnosis. Currently, the standard treatment for patients whose cancer has spread to their armpit (axilla) is to remove all these lymph nodes (axillary node clearance, ANC), even if only one or two are affected. One in three patients, however, will experience major life changing complications after this operation. These include permanent swelling of the arm (lymphoedema), long-term pain, and problems with shoulder function. These complications dramatically affect patients’ quality of life and as they are life-long, are costly to the NHS.

Removal of all the lymph nodes in the armpit was traditionally believed to give patients the best chance of surviving their breast cancer, but there is no evidence to show that this is needed 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 patients having life-changing, long-term complications. AIM To determine whether, in breast cancer patients with limited spread of the cancer to their armpit lymph nodes at diagnosis, compared to removing all the lymph nodes in the armpit (axillary node clearance), more targeted armpit surgery (TAD) reduces the risk of lymphoedema at 12 months after the operation without increasing the risk of the cancer returning.

METHODS

We will recruit 861 patients whose breast cancer has spread to only one or two lymph nodes in their armpit from 40 UK NHS Breast Units. One group will have an operation to remove all of their axillary lymph nodes (ANC, current standard of care) as part of their breast cancer surgery, the other will have the more targeted axillary surgery (TAD). Patients will be offered either ANC or TAD surgery by a process called randomisation to ensure that the groups are similar in terms of general health and other treatments received. This allows a fair comparison to be made between the two groups. We will compare how many patients have arm swelling (lymphoedema) 12 months after surgery. All patients will be followed up for five years to ensure that risk of the cancer returning in the armpit or breast after more targeted surgery is acceptable. We will also collect information about any problems patients experience after surgery, shoulder function, pain, quality of life and the costs of both operations.

PATIENT & PUBLIC INVOLVEMENT

This study was co-developed with our patient co-applicants to address the top research priority identified by ~200 patients and ~100 professionals in the recent James Lind Alliance Priority Setting exercise in breast cancer surgery. Our co-primary outcomes were chosen in collaboration with our patient group. Our patient co-applicants will be part of the trial management group and together with our patient advisory group will ensure that all aspects of the study are patient focused.

DISSEMINATION

Study results will be shared with the NHS, published in research journals, and presented at conferences. We will use our close links with key organisations to include the study findings in clinical guidelines. We will work with patient groups to share findings with participants and the public through meetings, newsletters and social media.