ABCSG 43 / INSEMA
Status: Treatment Phase & Follow-up
Comparison of axillary sentinel lymph node biopsy versus no axillary surgery in patients with stage I and II invasive breast cancer and breast-conserving surgery: a randomized prospective surgical trial
|Coordinating Investigator:||Michael Knauer (St. Gallen)|
|Start of study:||09/2015 (global), 03/2016 (national)|
|Sponsor:||University of Rostock|
Description and status:
This prospective surgical study headed by the University of Rostock investigates whether a sentinel lymph node biopsy (SLNB) could be refrained from if the axilla is clinically and sonographically normal. The first randomization step (“Rando 1”) was carried out only in Germany and in one Austrian trial site (Salzburg) and divided the patients into the arms „no SLNB“ or „SLNB“ in a 1:4 ratio. In the second randomization step (“Rando 2”), in which all additional Austrian ABCSG sites participated, those patients who had received an SLNB and had a maximum of one to three macro-metastases in the sentinel lymph nodes, were randomized either into an axillary dissection (ALND) arm or waiver on the same. Patients with four or more affected sentinel lymph nodes were completely operated on via ALND. The primary endpoint is invasive disease-free survival (IDFS) after breast-conserving surgery. A total of 158 patients were randomized at Austrian sites, 132 of these in Salzburg who took part in both randomization steps. Patients are currently in follow-up.