Selective Rather Than Complete Removal of Axillary Lymph Nodes in Breast Cancer

Breast cancer is the most common cancer among women, but it can also affect men. If the disease spreads to the lymph nodes in the armpit, the standard practice to date has been to surgically remove all the lymph nodes in that area. However, this procedure—known as axillary dissection—can cause long-term side effects, including swelling of the arm (lymphedema), sensory disturbances, limited range of motion, and chronic pain.

The goal of the TAXIS study is to investigate a less invasive surgical procedure—known as tailored axillary surgery (TAS). In this procedure, only the abnormal or previously marked lymph nodes in the armpit are removed, supplemented by targeted radiation therapy. All study participants initially undergo TAS. Afterward, participants are randomly assigned to one of two groups (two-arm study): In the first group (ALND group), TAS is followed by the complete removal of all remaining lymph nodes in the armpit (axillary lymph node dissection). Afterward, the adjacent lymphatic drainage area is irradiated, but not the operated armpit region itself. In the second group (without ALND), no further surgery is performed; instead, the entire axillary region and the adjacent lymphatic drainage area are treated with radiation. The goal of the study is to determine whether targeted surgery combined with radiation therapy offers comparable effectiveness in preventing recurrences, but with fewer side effects and a better quality of life for patients.

Eligible participants include women and men aged 18 and older with newly diagnosed breast cancer or a recurrence in the breast, provided that the initial cancer occurred at least three years ago. A prerequisite for participation in the study is the detection of tumor cells in at least one axillary lymph node—either through physical examination, imaging, or a biopsy. Patients who have already received chemotherapy may also be included, provided that cancer cells are still detectable in the lymph nodes. Excluded are, among others, individuals with existing distant metastases (spread to other parts of the body, Stage IV), prior surgery or radiation therapy to the axillary region, and other active cancers.