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Evaluating axillary treatment options for breast cancer patients after chemotherapy

ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy

NA · University Hospitals of Derby and Burton NHS Foundation Trust · NCT04109079

This study is testing if early stage breast cancer patients can skip extra treatments for their underarm area after chemotherapy if their lymph nodes show no signs of cancer.

Quick facts

PhaseNA
Study typeInterventional
Enrollment1900 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust (other)
Drugs / interventionschemotherapy
Locations98 sites (Dublin and 97 other locations)
Trial IDNCT04109079 on ClinicalTrials.gov

What this trial studies

This study aims to determine if for early stage breast cancer patients with axillary nodal metastases, omitting further axillary treatment after neoadjuvant chemotherapy is as effective as traditional treatments. Participants will be randomly assigned to either receive axillary lymph node dissection or radiotherapy, or to omit these treatments if they show no residual cancer in lymph nodes post-chemotherapy. The study will assess disease-free survival and the risk of developing lymphoedema over a five-year period. This pragmatic, multicenter trial will involve patients aged 18 and older with specific breast cancer staging and treatment histories.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with early stage breast cancer and confirmed axillary nodal metastases who have undergone neoadjuvant chemotherapy.

Not a fit: Patients with advanced breast cancer or those who do not respond to neoadjuvant chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for invasive axillary treatments, minimizing complications like lymphoedema for breast cancer patients.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating that omitting extensive axillary treatment may be feasible for certain patient populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18
* Male or female
* cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)

  o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are eligible for the study.
* FNA or core biopsy confirmed axillary nodal metastases at presentation
* Oestrogen receptor and HER2 status evaluated on primary tumour
* Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
* Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
* Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed.

  * If a single tracer SNB is performed: the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
  * If the node is not marked or the marked node is not removed: the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g., fibrosis or scarring in at least one node and at least 3 nodes removed.
  * If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:

    1. involved node was marked and removed during SNB; and
    2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed.
* No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)
* Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study
* Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed.

5.2. Exclusion Criteria

Participants will be excluded if they have any one of the following:

* Bilateral synchronous invasive breast cancer
* Sentinel node biopsy prior to NACT
* Previous axillary nodal surgery on the same body side as the scheduled targeted sampling
* Any previous cancer within last 5 years or concomitant malignancy except

  * basal or squamous cell carcinoma of the skin
  * in situ carcinoma of the cervix
  * in situ or stage 1 melanoma
  * contra- or ipsilateral in situ breast cancer
  * chronic lymphocytic leukaemia not on treatment

Where this trial is running

Dublin and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Breast Cancer, Sentinel Lymph Node, Neoplasm, Breast, neoadjuvant chemotherapy, sentinel node biopsy, breast cancer, tattooing node, marking node

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.