ATNEC
Research type
Research Study
Full title
ATNEC - Axillary management in T1-3N1M0 breast cancer patients with needle biopsy proven nodal metastases at presentation after neoadjuvant chemotherapy
IRAS ID
280105
Contact name
Amit Goyal
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 11 months, 28 days
Research summary
Early stage breast cancer patients with abnormal looking armpit lymph glands on an ultrasound scan will have a sample (needle biopsy) of this lymph gland taken. If the sample shows cancer cells are present, patients are often given chemotherapy before surgery (called neoadjuvant chemotherapy) to shrink these cancer cells before their operation. Currently after chemotherapy, all patients undergo breast surgery (lumpectomy or mastectomy) and treatment to their armpit (either removal of all armpit lymph glands or radiotherapy to the armpit).
Neoadjuvant chemotherapy results in complete disappearance of cancer in the lymph glands in around 40-70% of patients. For these patients there may be no extra benefit from more treatment to their armpit. Any extra armpit treatment may damage lymphatic drainage from the arm, which could lead to arm swelling (lymphoedema), restricted shoulder movement, pain, numbness and other sensory problems. These side effects make some daily activities difficult for patients, they are distressing and affect quality of life. They are costly to the NHS in terms of treatments such as physiotherapy and attendance at lymphoedema clinics.
The aim of our study is to find out whether stopping further armpit treatment for patients with no cancer in the lymph glands after chemotherapy is safe, in terms of risk of cancer coming back and less lymphoedema cases at 5 years. After neoadjuvant chemotherapy and at the time of breast surgery, patients will undergo removal of at least 3 lymph glands from the armpit. If there is no cancer in the removed glands, patients will be randomly allocated to receive standard armpit treatment or no further treatment to the armpit.
Results of this study could benefit patients by avoiding unnecessary treatment to the armpit and thus reducing future problems with the arm and shoulder, and possibly improved quality of life and reduced healthcare costs.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0232
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion