Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust

About this trial

The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.

Eligibility criteria

Qualifiers

Age ≥ 18

Male or female

cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)

FNA or core biopsy confirmed axillary nodal metastases at presentation

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Axillary lymph node dissection
  • Axillary radiotherapy
  • Breast or chest wall radiotherapy

Treatment groups

1,900 Participants
are divided into 2 treatment groups