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Clinical Trial Summary

RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy. PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.


Clinical Trial Description

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 procedure, which involves the selective removal of the first few affected lymph nodes, 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 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 combines the removal of palpably suspicious nodes with the sentinel procedure. 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. The main objective of the trial is to show that TAS and axillary radiotherapy (RT) is non-inferior to ALND in terms of disease-free survival of node positive breast cancer patients at high risk of recurrence in the era of effective systemic therapy and extended regional nodal irradiation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03513614
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact Walter P. Weber, Prof.
Phone +41 61 328 61 49
Email walter.weber@usb.ch
Status Recruiting
Phase N/A
Start date August 7, 2018
Completion date December 2036

See also
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Recruiting NCT04826211 - Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI N/A
Recruiting NCT05462457 - TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes
Recruiting NCT05333328 - OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk Phase 4
Not yet recruiting NCT05676866 - Evaluation of Targeted Axillary Lymph Node Dissection in Node Positive Breast Cancer Patients Post Neo Adjuvant Therapy Phase 4
Active, not recruiting NCT02515110 - Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer N/A