OPBC-03 / SAKK 23/16 / IBCSG 57-18 / ABCSG-53 / GBG-101. 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.

The removal of all lymph nodes in the armpit through conventional
axillary dissection has been standard care for all patients with breast
cancer for almost a century. In the nineties, the sentinel lymph node
(SLN) procedure, which involves the selective removal of the first
few lymph nodes in the lymphatic drainage system, was introduced
in clinical practice. Today, conventional axillary dissection is still
performed on many women with breast cancer that has spread to
the nodes. It is the cause for relevant morbidity in the form of
lymphedema, impairment of shoulder mobility, sensation disorders
and chronic pain in as much as one third of all women undergoing
the procedure.

The TAXIS trial will evaluate the optimal treatment for breast cancer
patients with confirmed nodal disease at first diagnosis in terms of
surgery and radiotherapy. In particular, it will investigate the value of
tailored axillary surgery (TAS), a new technique that aims at
selectively removing the positive lymph nodes. TAS is a promising
procedure that may significantly decrease morbidity in breast cancer
patients by avoiding surgical overtreatment.
This trial has the potential to establish a new worldwide treatment
standard with hopefully less side effects and a better quality of life,
while keeping the same efficacy as provided by radical surgery.