Intergroup-Sentinel-Mamma (INSEMA)-Trial - GBG 75
Comparison of axillary sentinel lymph node biopsy versus no axillary surgery in patients with early-stage invasive breast cancer and breast-conserving surgery: a randomized prospective surgical trial.
Introduction
A randomized, multicenter study comparing axillary sentinel lymph node biopsy vs. no axillary sentinel lymph node biopsy in patients with planned breast-conserving therapy.
This study is a cooperation between the Rostock University Women's Clinic at Klinikum Südstadt and GBG Forschungs GmbH. The sponsor of the study is the University Medical Center Rostock. The study is funded by the German Cancer Aid.
The study is being conducted under the NCT number 02466737.
News
We would like to inform you that the end of recruitment in the INSEMA study was reached on 24.04.2019.
We would like to thank you for your commitment.
Design
Currently, axillary surgery for breast cancer is considered as staging procedure that does not seem to influence breast cancer mortality, since the risk of developing metastasis depends mainly on the biological behaviour of the primary (seed-and-soil model). Based on this, the postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement.
The goal of the present study is to show that early-stage breast cancer patients with reduced extent of axillary surgery are not inferior regarding disease-free survival outcome compared with the standard arm. All patients will be first randomized to either no axillary surgical intervention or axillary sentinel lymph node biopsy (SLNB). Patients with SLNB and pN+(sn) status will be secondly randomized to either SLNB alone or completion axillary lymph node dissection (ALND) in cases with less than four involved nodes (one to three macrometastases). Patients with four or more metastatic sentinel lymph nodes should undergo completion ALND.
Postoperative systemic treatment should be based on local multidisciplinary tumor board recommendation according to the current German AGO and S3 guidelines. For women who are treated with breast-conserving surgery, the most common site of local recurrence is the conserved ipsilateral breast itself. Thus, whole-breast radiation therapy after breast-conserving surgery is mandatory and should be performed according to the current guidelines (S3, AGO, DEGRO).
The inclusion and exclusion criteria, as well as more detailed information on the study design, can be found in the short protocol on the list of documents.
