Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.
Female patient with unilateral invasive breast cancer and cN1-3
Pathologically proven positive axillary lymph node
Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla
Clinically node negative breast cancer before NST
Bilateral invasive breast cancer
Neoadjuvant endocrine therapy
Distant metastases (including oligometastatic disease)
Female patients with unilateral invasive breast cancer and cN1-3, with a minimum of one pathologically proven positive axillary lymph node, treatment with neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla.
Cohort
Prospective
Not listed
Disease free survival (DFS)
DFS is defined as the time interval between the date of diagnosis until the date that a patient survives without any signs or symptoms of the disease.
Breast cancer specific survival (BCSS)
BCSS is defined as the time interval between the date of diagnosis until death from the disease.
Overall survival (OS)
OS is defined as the time interval between the date of diagnosis until death from any cause.
Axillary recurrence rate (ARR)
ARR is defined as tumor recurrence and as residual tumor that became clinically apparent in the ipsilateral axillary lymph nodes (pathologically proven).
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Maastricht University Medical Center
Lead sponsor
Erasmus Medical Center
Collaborator
The Netherlands Cancer Institute
Collaborator
