Evaluating axillary treatment options for breast cancer patients after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St Vincent's University Hospital - St Vincent's Healthcare Group
  Dublin, Ireland Recruiting
• St Luke's Hospital - St Luke's Radiation Oncology Network
  Dublin, Ireland Recruiting
• Beaumont Hospital - Royal College of Surgeons in Ireland
  Dublin, Ireland Recruiting
• Galway University Hospitals - Saolta University Health Care Group
  Galway, Ireland Recruiting
• Airedale General Hospital - Airedale NHS Foundation Trust
  Keighley, Bd20 6td, United Kingdom Recruiting
• Cumberland Infirmary - North Cumbria Integrated Care NHS Foundation Trust
  Carlisle, Ca2 7hy, United Kingdom Recruiting

+48 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Amit Goyal, MS, MD, FRCS — Royal Derby Hospital, Derby, UK
• Study coordinator: Amit Goyal, MS, MD, FRCS
• Email: amit.goyal@nhs.net
• Phone: +44 1332785538

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.