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ACTIVE NOT RECRUITING

NCT02466737

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

Sponsor: University of Rostock

View on ClinicalTrials.gov

Summary

Although there is no doubt that the presence of lymph node metastases worsens prognosis of a patient, unambiguous evidence to support lymph node dissection is still lacking. For many solid tumors, the role of lymph node dissection is yet controversial, and may depend on the tumor type and the stage of patient presentation for diagnosis. Axillary surgery for breast cancer is now considered as staging procedure that does not seem to influence breast cancer mortality. Women with breast cancer have benefitted greatly from a series of carefully performed randomized controlled trial focusing on axillary surgery. The objective of INSEMA is to show that less axillary surgery is better, in that oncological outcomes are the same and less surgical intervention will result in fewer surgical complications.

Official title: 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. Intergroup-Sentinel-Mamma (INSEMA)-Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5505

Start Date

2015-09

Completion Date

2025-06

Last Updated

2024-12-19

Healthy Volunteers

Conditions

Breast Cancer

Interventions

PROCEDURE

no axillary surgery versus SLNB

in cases with newly diagnosed breast cancer and clinically negative axillary status

PROCEDURE

SLNB versus completion ALND

in cases with 1-3 macrometastases in sentinel lymph nodes

Locations (150)

BGZ Dornbirn, Gynäkologie

Dornbirn, Austria

LKH Uni-Klinikum Graz, Gynäkologie

Graz, Austria

Ordensklinikum-BHS

Linz, Austria

Kepler Universitätsklinikum

Linz, Austria

KH der Barmherzigen Brüder

Saint Veit/Glan, Austria

Universitätsfrauenklinik Salzburg

Salzburg, Austria

Hanusch-Krankenhaus, Brustzentrum

Vienna, Austria

Landes-Krankenhaus Wolfsberg, Chirurgie

Wolfsberg, Austria

Ostalb-Klinikum, Brustzentrum Aalen

Aalen, Baden-Wurttemberg, Germany

Caritas-Krankenhaus Brustzentrum Tauberfranken

Bad Mergentheim, Baden-Wurttemberg, Germany

Klinikum Mittelbach Brustzentrum

Baden-Baden, Baden-Wurttemberg, Germany

Sana-Klinikum Biberach

Biberach, Baden-Wurttemberg, Germany

Krankenhaus Bietigheim

Bietigheim, Baden-Wurttemberg, Germany

Klinikum Böblingen

Böblingen, Baden-Wurttemberg, Germany

Fürst-Stirum-Klinik

Bruchsal, Baden-Wurttemberg, Germany

Brustzentrum Donau-Riß

Ehingen, Baden-Wurttemberg, Germany

Klinikum Esslingen

Esslingen am Neckar, Baden-Wurttemberg, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Frauenklinik Freudenstadt

Freudenstadt, Baden-Wurttemberg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Städtisches Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

ViDia Christliche Kliniken, Diakonissenkrankenhaus Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

St. Elisabethen Krankenhaus

Loerrach, Baden-Wurttemberg, Germany

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Helios Klinik Pforzheim

Pforzheim, Baden-Wurttemberg, Germany

Siloah St. Trudpert Klinikum

Pforzheim, Baden-Wurttemberg, Germany

Klinikum am Steinenberg

Reutlingen, Baden-Wurttemberg, Germany

Helios Klinik Rottweil

Rottweil, Baden-Wurttemberg, Germany

Rems-Murr Klinik

Schorndorf, Baden-Wurttemberg, Germany

Klinikum Tuttlingen

Tuttlingen, Baden-Wurttemberg, Germany

Universitätsfrauenklinik

Tübingen, Baden-Wurttemberg, Germany

Universitätsfrauenklinik Ulm

Ulm, Baden-Wurttemberg, Germany

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Rems-Murr Kliniken

Winnenden, Baden-Wurttemberg, Germany

Klinikum St. Marien

Amberg, Bavaria, Germany

AN regiomed Klinikum Ansbach

Ansbach, Bavaria, Germany

Klinikum Aschaffenburg

Aschaffenburg, Bavaria, Germany

Hämatologisch-onkologische Praxis

Augsburg, Bavaria, Germany

Klinikum Bayreuth GmbH, Frauenklinik

Bayreuth, Bavaria, Germany

Kreisklinik Ebersberg

Ebersberg, Bavaria, Germany

Gynäkologische Praxis

Eggenfelden, Bavaria, Germany

Klinikum Fürth

Fürth, Bavaria, Germany

Klinikum Kempten-Oberallgäu

Kempten (Allgäu), Bavaria, Germany

Klinikum Landshut

Landshut, Bavaria, Germany

Klinikum Fichtelgebirge gGmbH, Brustzentrum

Marktredwitz, Bavaria, Germany

Klinikum Memmingen

Memmingen, Bavaria, Germany

Klinikum der Universität München

München, Bavaria, Germany

Klinikum Harlaching, Frauenklinik

München, Bavaria, Germany

Klinikum Passau

Passau, Bavaria, Germany

Frauenklinik der Universität Regensburg, Caritas-Krankenhaus St. Josef

Regensburg, Bavaria, Germany

Klinikum Starnberg

Starnberg, Bavaria, Germany

Klinikum Traunstein

Traunstein, Bavaria, Germany

Kliniken Nordoberpfalz AG, Brustzentrum Weiden

Weiden, Bavaria, Germany

Rotkreuzklinik Würzburg

Würzburg, Bavaria, Germany

Klinikum Mitte, Missio Brustzentrum

Würzburg, Bavaria, Germany

Städtisches Klinikum Brandenburg

Brandenburg, Brandenburg, Germany

Carl-Thiem-Klinikum

Cottbus, Brandenburg, Germany

Ev. Krankenhaus, Frauenklinik

Ludwigsfelde, Brandenburg, Germany

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, Germany

St. Joseph Stift

Bremen, City state Bremen, Germany

DIAKO Krankenhaus Bremen

Bremen, City state Bremen, Germany

Universitätsklinikum Hamburg, Brustzentrum

Hamburg, Hamburg, Germany

Agaplesion Diakonieklinikum, Brustzentrum

Hamburg, Hamburg, Germany

Gynäkologische Praxisklinik Harburg

Hamburg, Hamburg, Germany

Albertinen-Krankenhaus, Brustzentrum

Hamburg, Hamburg, Germany

Agaplesion Markus Krankenhaus

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Brustzentrum

Frankfurt am Main, Hesse, Germany

Klinikum Frankfurt Höchst

Frankfurt am Main, Hesse, Germany

Main-Kinzig-Kliniken Gelnhausen

Gelnhausen, Hesse, Germany

Klinikum Hanau GmbH

Hanau, Hesse, Germany

Kreiskrankenhaus Bergstraße gGmbH

Heppenheim an der Bergstrasse, Hesse, Germany

Elisabeth Krankenhaus Kassel

Kassel, Hesse, Germany

Klinikum Kassel

Kassel, Hesse, Germany

Sana Klinikum Offenbach

Offenbach, Hesse, Germany

St. Josefs-Hospital, Frauenklinik

Wiesbaden, Hesse, Germany

Asklepios Paulinenklinik

Wiesbaden, Hesse, Germany

Helios Dr. Horst Schmidt Klinikum

Wiesbaden, Hesse, Germany

AKH Celle, Brustzentrum

Celle, Lower Saxony, Germany

Franziskus Hospital Harderberg

Georgsmarienhütte, Lower Saxony, Germany

Helios Klinikum Gifhorn

Gifhorn, Lower Saxony, Germany

Henriettenstiftung Frauenklinik

Hanover, Lower Saxony, Germany

Vinzenzkrankenhaus Hannover

Hanover, Lower Saxony, Germany

MHH Frauenklinik

Hanover, Lower Saxony, Germany

St. Bernward Krankenhaus

Hildesheim, Lower Saxony, Germany

Bonifatius-Hospital, Brustzentrum

Lingen, Lower Saxony, Germany

Euregio-Klinik Brustzentrum Nordhorn

Nordhorn, Lower Saxony, Germany

Agaplesion Ev. Klinikum, Brustzentrum Schaumburg

Obernkirchen, Lower Saxony, Germany

Klinikum Osnabrück

Osnabrück, Lower Saxony, Germany

Diakoniekrankenhaus, Frauenklinik

Rotenburg (Wümme), Lower Saxony, Germany

Klinikum Wolfsburg, Frauenklinik

Wolfsburg, Lower Saxony, Germany

Universität Greifswald, Frauenklinik

Greifswald, Mecklenburg-Vorpommern, Germany

Dietrich Bonhoeffer Klinikum, Brustzentrum

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Universitäts-Frauenklinik

Rostock, Mecklenburg-Vorpommern, Germany

Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, Germany

Augusta-Klinik

Bochum, Nordrhein, Germany

Universitätsfrauenklinik Bonn

Bonn, Nordrhein, Germany

Marienhospital Bottrop

Bottrop, Nordrhein, Germany

Uniklinik Köln

Cologne, Nordrhein, Germany

St. Elisabeth Krankenhaus, Brustzentrum

Cologne, Nordrhein, Germany

Frauenklinik der H.-Heine-Universität

Düsseldorf, Nordrhein, Germany

Universitätsklinikum Essen Frauenklinik

Essen, Nordrhein, Germany

Kliniken Essen-Mitte

Essen, Nordrhein, Germany

Klinikum Märkische Kliniken, Brustzentrum

Lüdenscheid, Nordrhein, Germany

Klinikum Lünen, Brustzentrum

Lünen, Nordrhein, Germany

St. Franziskus-Hospital

Münster, Nordrhein, Germany

Universitätsklinikum Münster

Münster, Nordrhein, Germany

Marienkrankenhaus

Schwerte, Nordrhein, Germany

St. Marienkrankenhaus, Frauenklinik

Siegen, Nordrhein, Germany

St. Josef-Hospital, BZ Rhein-Sieg

Troisdorf, Nordrhein, Germany

Katharinen-Hospital, Brustzentrum

Unna, Nordrhein, Germany

Marien-Hospital

Wesel, Nordrhein, Germany

Westpfalz Klinikum

Kaiserslautern, Rhineland-Palatinate, Germany

BZ Mittelrhein Koblenz+Mayen

Koblenz, Rhineland-Palatinate, Germany

Klinikum Ludwigshafen

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Diakonissen-Stiftungs-Krankenhaus Speyer

Speyer, Rhineland-Palatinate, Germany

Stadtkrankenhaus Worms

Worms, Rhineland-Palatinate, Germany

Krankenhaus St. Elisabeth und St. Barbara

Halle, Saint, Germany

Universität Halle/Saale, Frauenklinik

Halle, Saint, Germany

Klinik St. Marienstift

Magdeburg, Saint, Germany

Altmark-Klinikum Brustzentrum

Salzwedel, Saint, Germany

Johanniter-Krankenhaus, Frauenklinik

Stendal, Saint, Germany

Harzklinikum, Brustzentrum Harz

Wernigerode, Saint, Germany

Brustzentrum Nordsachsen

Borna, Saxony, Germany

Diakonissenkrankenhaus

Dresden, Saxony, Germany

Krankenhaus St. Joseph-Stift

Dresden, Saxony, Germany

Universität Dresden, Frauenklinik

Dresden, Saxony, Germany

Städtisches Klinikum

Görlitz, Saxony, Germany

Universitätsklinikum Leipzig, Brustzentrum

Leipzig, Saxony, Germany

St. Elisabeth Krankenhaus

Leipzig, Saxony, Germany

Klinikum Obergöltzsch Rodewisch

Rodewisch, Saxony, Germany

Helios Klinik

Schkeuditz, Saxony, Germany

Sana-Klinik

Eutin, Schleswig-Holstein, Germany

DIAKO Diakonissenkrankenhaus

Flensburg, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Hostein

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Charite Campus Mitte