Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS). A multicenter randomized phase III trial

In the past decades, the complete removal of all lymph nodes in the armpit was the standard treatment for breast cancer patients. This causes massive morbidity in one-third of patients with decreased quality of life. In the past years, this radical operation was slowly abandoned in patients without tumor signs in their lymph nodes. Currently, it is unclear what the optimal treatment is for patients with lymph node metastases in their armpit.

The main goals of this study will be: Is it sufficient to operate the so-called sentinel lymph nodes and the affected lymph nodes within the armpit (tailored surgery), or is the radical removal of all armpit lymph nodes safer and still required? What magnitude of radiotherapy should these women receive? Besides, the differences in quality of life of patients after the two surgical interventions will be defined.

One-half of the 1500 patients will undergo radical surgery and the other half will receive a tailored surgery of their lymph nodes. This study will permit to establish worldwide a new treatment standard with fewer side effects and a better quality of life while keeping the same efficacy as that provided by radical surgery.