A Comparison of Different Surgical Procedures for Axillary Lymph Nodes in Early-Stage Breast Cancer

The removal of axillary lymph nodes has long been an established part of breast cancer treatment. Tumor cells can spread to other parts of the body via the lymphatic system, which can then lead to metastasis. The axillary lymph nodes are an important stop along this path, so examining these lymph nodes provides valuable information about the extent of the tumor. When lymph nodes are removed, tumor tissue is also removed if the nodes are affected. The removal is performed surgically, using various strategies. These include the removal of only the so-called sentinel lymph node, the targeted removal of several lymph nodes suspected of being affected, and the prophylactic removal of many (at least 10) axillary lymph nodes, some of which may not be affected.

The goal of the AXSANA study is to compare these three approaches with regard to the following key questions: long-term tumor-free status and adverse effects resulting from the surgery itself. The study also aims to determine which surgical approach is optimal for patients whose lymph nodes were tumor-positive at diagnosis but are tumor-free following neoadjuvant therapy. The study has 3 arms; however, patient assignment is open-label (not blinded) and non-randomized, meaning that you and your doctor will jointly decide which strategy to choose. This is a purely observational study; no surgical procedures that do not currently meet the standard of care will be investigated. The observation period lasts for a maximum of 5 years. A prerequisite for participation is that neoadjuvant therapy has been completed beforehand; however, the specific medications used are not specified. The study ends either after 5 years or if the tumor recurs or metastasizes before then.