ABCSG 53 / TAXIS / OPBC-03 / SAKK 23/16
Status: Treatment Phase & Follow-up
Tailored axillary surgery (TAS) with or without axillary lymph node dissection (ALND) followed by radiotherapy in patients with clinically node-positive breast cancer. A multicenter randomized phase III trial.
| Coordinating Investigator: | Daniel Egle, Innsbruck |
| Study Start: | 08/2018 (global), 12/2019 (national) |
| Sample Size: | >1.580 |
| Sponsor: | University Hospital Basel |
Study Overview and Status:
The surgical TAXIS trial tests the hypothesis that Axillary Lymph Node Dissection (ALND) is no longer necessary for confirmed nodal disease at first diagnosis of breast cancer in the era of extended regional nodal irradiation in clinically node positive patients in the adjuvant setting or incomplete response of nodal disease in the neoadjuvant setting. In many patients undergoing ALND, the number of negative lymph nodes removed exceeds the number of tumor-affected nodes. Removing multiple unaffected lymph nodes increases morbidity with no oncologic benefit. It is a consequence of radical surgery that follows the principle of complete tissue removal within the anatomical borders of the axilla. Benefits and harms of this approach must be re-assessed. TAXIS investigates Tailored Axillary Surgery (TAS), a tailored approach focusing on the removal of tumor-affected lymph nodes while limiting the extent of surgery to minimize the number of negative nodes removed. We hypothesize that TAS is not less effective in curing patients and preventing recurrences compared to ALND and spares patient’s significant morbidity.
After having undergone TAS, trial participants are randomized 1:1 intraoperatively to either receive ALND and regional nodal irradiation or regional nodal irradiation including the axilla.
The first participant was enrolled in 2019 in one of seven participating sites in Austria. Until the end of recruitment on 31st December 2025, 187 participants were randomized in Austria and 1.580 in 14 countries globally. The study is currently in the follow up phase, which lasts until 10 years after the last participant was randomized.
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