Design Paper: A Prospective, Multicenter, Single-arm, Phase II Trial of Tailored Axillary Surgery in Patients with Clinically Node-positive Breast Cancer in the Upfront Surgery Setting.

Introduction: This prospective, multicenter, single-arm Phase II trial investigates the feasibility and the safety of tailored axillary surgery (TAS) in patients with clinically node-positive breast cancer who are undergoing upfront surgery. The trial aims to establish the criteria for safely omitting axillary lymph node dissection (ALND) in these cases, potentially shifting breast cancer management by minimizing surgical complications and preserving the patients' quality of life (QOL).

Methods: The study includes patients who were diagnosed with invasive breast cancer, particularly those with limited metastatic lymph nodes. The primary objective of this work is to determine the specific combination of clinical and pathological factors that would result in a non-TAS lymph node metastasis proportion of less than 10%. The secondary objectives include assessing the identification rate of the metastatic lymph nodes, the incidence of upper limb lymphedema, and the QOL measures.

Results: The results will identify the patient eligibility criteria for the Phase III TAS trial, potentially allowing the omission of ALND in selected patients. This may lead to reduced surgical complications and better preservation of the QOL of patients with breast cancer.

Conclusions: The trial's outcome will contribute to the development of the criteria for safely omitting ALND in certain patients with clinically node-positive breast cancer. This approach aims to enhance breast cancer management by reducing surgical burden and improving the patient outcomes.jRCTs: 061220113.