Axillary management in cT1-3N1M0 breast cancer patients with needle biopsy proven nodal metastases at presentation after neoadjuvant chemotherapy
About this trial
The ATNEC Study is currently open at:
- University Hospital Galway
- St. Luke’s Radiation Oncology Network (SLRON)
- St. Vincent’s Hospital
- St. James’s Hospital
- Beaumont Hospital
What is the goal of this study?
The goal of the ATNEC study is to find out whether patients with early-stage breast cancer who had cancer in the armpit lymph glands at diagnosis but have no remaining cancer in the lymph nodes after neoadjuvant chemotherapy (NACT) can safely avoid further armpit (axillary) treatment such as axillary radiotherapy. The study aims to determine whether leaving out this extra treatment is just as effective as giving it in terms of cancer control, and whether it can reduce long-term side effects, such as lymphoedema (arm swelling) and discomfort in the arm or shoulder.
What happens to patients as part of this trial?
- Patients with confirmed cancer in the armpit lymph glands at diagnosis first receive neoadjuvant chemotherapy (chemotherapy before their surgery).
- If no cancer is found in the lymph nodes removed as part of the breast surgery after chemotherapy, patients may be invited to participate in the trial.
- After informed consent, participants are randomly assigned (by computer, 1:1) to one of two groups:
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No radiation to the armpit after surgery
- Radiotherapy to the armpit after surgery
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All participants will receive radiation to their breast regardless of which group they are in.
- No additional tests or extra hospital visits are required beyond routine care.
- Participants are followed for at least five years, including completion of quality-of-life questionnaires at study entry and then annually for five years.
Here is a patient speaking about the ATNEC study:
Who can take part?
You may be eligible if:
- You are 18 or older,
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You were diagnosed with early-stage breast cancer that had spread to at least one lymph gland in your armpit.
(In some people, the main breast tumour is very small or cannot be easily seen, and this is still OK.) -
A needle biopsy confirmed cancer in a lymph gland in your armpit before you started chemotherapy.
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You have already received chemotherapy before surgery (neoadjuvant chemotherapy).
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During your breast surgery, at least three lymph glands were removed and tested, using a procedure called a sentinel lymph node biopsy.
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The results showed that the chemotherapy had cleared all cancer from the lymph glands, meaning no cancer cells were found.
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You meet certain technical requirements related to how the lymph gland was marked and tested (your clinical team checks this for you).
Study Oversight
Professor Aoife Lowry the Chief Investigator of the study in Ireland.
The study is sponsored nationally by RCSI
University Hospitals of Derby & Burton NHS Foundation Trust are the international study sponsors and Professor Amit Goyal is the Sponsor-Investigator.
The below video gives more information on the ATNEC Study: