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Could skipping axillary surgery be safe for early breast cancer?

NCT ID NCT02466737

Disease control Sponsor: University of Rostock Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two approaches for women with early-stage invasive breast cancer undergoing breast-conserving surgery: no axillary surgery versus sentinel lymph node biopsy. The goal is to see if avoiding axillary surgery leads to the same cancer outcomes while reducing complications like arm swelling. Over 5,500 participants are enrolled, and the main measure is invasive disease-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
procedure: no axillary surgery versus sentinel lymph node biopsy
What this could lead to
If successful, this could show that many women with early breast cancer can safely avoid axillary surgery, reducing arm swelling and other side effects.
What could go wrong
This is a large trial, but it's testing non-inferiority—meaning it aims to prove that less surgery is not worse. There is a small risk that skipping surgery might miss cancer spread, though prior studies suggest this is unlikely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

5,505 people

The number who actually took part.

Started

Sep 2015

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent prior to beginning breast-conserving surgery, including expected cooperation of the patients for follow-up, must be obtained and documented according to the local regulatory requirements * Histologically confirmed unilateral primary invasive carcinoma of the breast (core biopsy or open biopsy). Multifocal or multicentric tumors are allowed if breast-conserving surgery is planned * Age at diagnosis at least 18 years * Preoperative imaging techniques with estimated tumor size of \<5 cm (iT1/iT2 irrespective of hormone sensitivity or HER2 status) * Clinically and sonographically tumor-free axilla prior to core biopsy (cN0/iN0) * In cases with cN0 and iN+, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required before randomization * No clinical evidence for distant metastasis (M0) * Planned breast-conserving surgery (R0 resection) with postoperative external whole-breast irradiation (conventional fractionation or hypofractionation) Exclusion Criteria: * History of malignancy within last 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix * Time since core biopsy \>3 months (optimal \<1 month) * Previous and already (neoadjuvant) treated invasive breast carcinoma * Histologically non-invasive breast carcinoma * cT3/T4 or iT3/T4 tumors * pregnant or lactating patients * Planned total mastectomy (e.g. multicentric tumors ) * Planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques * Male patients

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • AKH Celle, Brustzentrum

    Celle, Lower Saxony, 29223, Germany

  • AN regiomed Klinikum Ansbach

    Ansbach, Bavaria, 91522, Germany

  • Agaplesion Diakonieklinikum, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 20259, Germany

  • Agaplesion Ev. Klinikum, Brustzentrum Schaumburg

    Obernkirchen, Lower Saxony, 31683, Germany

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431, Germany

  • Albertinen-Krankenhaus, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 22457, Germany

  • Altmark-Klinikum Brustzentrum

    Hansestadt Salzwedel, Saxony-Anhalt, 29410, Germany

  • Asklepios Paulinenklinik

    Wiesbaden, Hesse, 65197, Germany

  • Augusta-Klinik

    Bochum, Nordrhein, 44791, Germany

  • BGZ Dornbirn, Gynäkologie

    Dornbirn, 6850, Austria

  • BZ Mittelrhein Koblenz+Mayen

    Koblenz, Rhineland-Palatinate, 56073, Germany

  • Bonifatius-Hospital, Brustzentrum

    Lingen, Lower Saxony, 49808, Germany

  • Brustzentrum Donau-Riß

    Ehingen, Baden-Wurttemberg, 89584, Germany

  • Brustzentrum Nordsachsen

    Borna, Saxony, 04552, Germany

  • Caritas-Krankenhaus Brustzentrum Tauberfranken

    Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

  • Carl-Thiem-Klinikum

    Cottbus, Brandenburg, 03046, Germany

  • Charite Campus Mitte

    Berlin, State of Berlin, 10117, Germany

  • DIAKO Diakonissenkrankenhaus

    Flensburg, Schleswig-Holstein, 24939, Germany

  • DIAKO Krankenhaus Bremen

    Bremen, Free Hanseatic City of Bremen, 28239, Germany

  • DRK Kliniken Köpenick

    Berlin, State of Berlin, 12559, Germany

  • DRK Krankenhaus, Brustzentrum

    Sömmerda, Thuringia, 99610, Germany

  • DRK-Kliniken Westend

    Berlin, State of Berlin, 14050, Germany

  • Diakoniekrankenhaus, Frauenklinik

    Rotenburg (Wümme), Lower Saxony, 27356, Germany

  • Diakonissen-Stiftungs-Krankenhaus Speyer

    Speyer, Rhineland-Palatinate, 67346, Germany

  • Diakonissenkrankenhaus

    Dresden, Saxony, 01099, Germany

  • Dietrich Bonhoeffer Klinikum, Brustzentrum

    Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

  • Elisabeth Krankenhaus Kassel

    Kassel, Hesse, 34117, Germany

  • Euregio-Klinik Brustzentrum Nordhorn

    Nordhorn, Lower Saxony, 48527, Germany

  • Ev. Krankenhaus, Frauenklinik

    Ludwigsfelde, Brandenburg, 14974, Germany

  • Evang. Waldkrankenhaus Spandau

    Berlin, State of Berlin, 13589, Germany

  • Franziskus Hospital Harderberg

    Georgsmarienhütte, Lower Saxony, 49124, Germany

  • Frauenklinik Freudenstadt

    Freudenstadt, Baden-Wurttemberg, 72250, Germany

  • Frauenklinik der H.-Heine-Universität

    Düsseldorf, Nordrhein, 40225, Germany

  • Frauenklinik der Universität Regensburg, Caritas-Krankenhaus St. Josef

    Regensburg, Bavaria, 93053, Germany

  • Fürst-Stirum-Klinik

    Bruchsal, Baden-Wurttemberg, 76646, Germany

  • Gynäkologische Praxis

    Eggenfelden, Bavaria, 84307, Germany

  • Gynäkologische Praxisklinik Harburg

    Hamburg, Free and Hanseatic City of Hamburg, 21673, Germany

  • Hanusch-Krankenhaus, Brustzentrum

    Vienna, 1140, Austria

  • Harzklinikum, Brustzentrum Harz

    Wernigerode, Saxony-Anhalt, 38855, Germany

  • Helios Dr. Horst Schmidt Klinikum

    Wiesbaden, Hesse, 65199, Germany

  • Helios Klinik

    Schkeuditz, Saxony, 04435, Germany

  • Helios Klinik Pforzheim

    Pforzheim, Baden-Wurttemberg, 75175, Germany

  • Helios Klinik Rottweil

    Rottweil, Baden-Wurttemberg, 78628, Germany

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19049, Germany

  • Helios Klinikum Gifhorn

    Gifhorn, Lower Saxony, 38518, Germany

  • Helios Klinikum Meiningen, Brustzentrum

    Meiningen, Thuringia, 98617, Germany

  • Helios Klinikum, Klinik für Gynäkologie

    Buch, State of Berlin, 13125, Germany

  • Henriettenstiftung Frauenklinik

    Hanover, Lower Saxony, 30559, Germany

  • Hufeland-Klinik Bad Langensalza

    Bad Langensalza, Thuringia, 99947, Germany

  • Hämatologisch-onkologische Praxis

    Augsburg, Bavaria, 86150, Germany

  • Johanniter-Krankenhaus, Frauenklinik

    Stendal, Saxony-Anhalt, 39576, Germany

  • KH der Barmherzigen Brüder

    Saint Veit/Glan, 9300, Austria

  • Katharinen-Hospital, Brustzentrum

    Unna, Nordrhein, 59423, Germany

  • Kepler Universitätsklinikum

    Linz, 4020, Austria

  • Klinik St. Marienstift

    Magdeburg, Saxony-Anhalt, 39110, Germany

  • Kliniken Essen-Mitte

    Essen, Nordrhein, 45136, Germany

  • Kliniken Nordoberpfalz AG, Brustzentrum Weiden

    Weiden, Bavaria, 92637, Germany

  • Klinikum Aschaffenburg

    Aschaffenburg, Bavaria, 63739, Germany

  • Klinikum Bayreuth GmbH, Frauenklinik

    Bayreuth, Bavaria, 95445, Germany

  • Klinikum Böblingen

    Böblingen, Baden-Wurttemberg, 71032, Germany

  • Klinikum Ernst von Bergmann

    Potsdam, Brandenburg, 14467, Germany

  • Klinikum Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

  • Klinikum Fichtelgebirge gGmbH, Brustzentrum

    Marktredwitz, Bavaria, 95615, Germany

  • Klinikum Frankfurt Höchst

    Frankfurt am Main, Hesse, 65929, Germany

  • Klinikum Fürth

    Fürth, Bavaria, 90766, Germany

  • Klinikum Hanau GmbH

    Hanau, Hesse, 63450, Germany

  • Klinikum Harlaching, Frauenklinik

    München, Bavaria, 81545, Germany

  • Klinikum Kassel

    Kassel, Hesse, 34125, Germany

  • Klinikum Kempten-Oberallgäu

    Kempten (Allgäu), Bavaria, 87439, Germany

  • Klinikum Landshut

    Landshut, Bavaria, 84034, Germany

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640, Germany

  • Klinikum Ludwigshafen

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

  • Klinikum Lünen, Brustzentrum

    Lünen, Nordrhein, 44534, Germany

  • Klinikum Memmingen

    Memmingen, Bavaria, 87700, Germany

  • Klinikum Mitte, Missio Brustzentrum

    Würzburg, Bavaria, 97074, Germany

  • Klinikum Mittelbach Brustzentrum

    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Klinikum Märkische Kliniken, Brustzentrum

    Lüdenscheid, Nordrhein, 58515, Germany

  • Klinikum Obergöltzsch Rodewisch

    Rodewisch, Saxony, 08228, Germany

  • Klinikum Osnabrück

    Osnabrück, Lower Saxony, 49076, Germany

  • Klinikum Passau

    Passau, Bavaria, 94032, Germany

  • Klinikum St. Marien

    Amberg, Bavaria, 92224, Germany

  • Klinikum Starnberg

    Starnberg, Bavaria, 82319, Germany

  • Klinikum Traunstein

    Traunstein, Bavaria, 83278, Germany

  • Klinikum Tuttlingen

    Tuttlingen, Baden-Wurttemberg, 78532, Germany

  • Klinikum Wolfsburg, Frauenklinik

    Wolfsburg, Lower Saxony, 38440, Germany

  • Klinikum am Steinenberg

    Reutlingen, Baden-Wurttemberg, 72764, Germany

  • Klinikum der Universität München

    München, Bavaria, 80337, Germany

  • Krankenhaus Bietigheim

    Bietigheim, Baden-Wurttemberg, 74321, Germany

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, Saxony-Anhalt, 06110, Germany

  • Krankenhaus St. Joseph-Stift

    Dresden, Saxony, 01307, Germany

  • Krankenhaus Waldfriede

    Berlin, State of Berlin, 14163, Germany

  • Kreisklinik Ebersberg

    Ebersberg, Bavaria, 85560, Germany

  • Kreiskrankenhaus Bergstraße gGmbH

    Heppenheim an der Bergstrasse, Hesse, 64646, Germany

  • LKH Uni-Klinikum Graz, Gynäkologie

    Graz, 8036, Austria

  • Landes-Krankenhaus Wolfsberg, Chirurgie

    Wolfsberg, 9400, Austria

  • MHH Frauenklinik

    Hanover, Lower Saxony, 30625, Germany

  • Main-Kinzig-Kliniken Gelnhausen

    Gelnhausen, Hesse, 63571, Germany

  • Marien-Hospital

    Wesel, Nordrhein, 46483, Germany

  • Marienhospital Bottrop

    Bottrop, Nordrhein, 46236, Germany

  • Marienkrankenhaus

    Schwerte, Nordrhein, 58239, Germany

  • Ordensklinikum-BHS

    Linz, 4010, Austria

  • Ostalb-Klinikum, Brustzentrum Aalen

    Aalen, Baden-Wurttemberg, 73430, Germany

  • Park-Klinik Weißensee

    Berlin, State of Berlin, 13086, Germany

  • Rems-Murr Klinik

    Schorndorf, Baden-Wurttemberg, 73614, Germany

  • Rems-Murr Kliniken

    Winnenden, Baden-Wurttemberg, 71364, Germany

  • Rotkreuzklinik Würzburg

    Würzburg, Bavaria, 97070, Germany

  • SRH Waldklinikum

    Gera, Thuringia, 07548, Germany

  • SRH Zentralklinikum Suhl

    Suhl, Thuringia, 98527, Germany

  • Sana Klinikum Berlin-Lichtenberg

    Berlin, State of Berlin, 10365, Germany

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069, Germany

  • Sana-Klinik

    Eutin, Schleswig-Holstein, 23701, Germany

  • Sana-Klinikum Biberach

    Biberach, Baden-Wurttemberg, 88400, Germany

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, Baden-Wurttemberg, 78050, Germany

  • Siloah St. Trudpert Klinikum

    Pforzheim, Baden-Wurttemberg, 75179, Germany

  • St. Bernward Krankenhaus

    Hildesheim, Lower Saxony, 31134, Germany

  • St. Elisabeth Krankenhaus

    Leipzig, Saxony, 04277, Germany

  • St. Elisabeth Krankenhaus, Brustzentrum

    Cologne, Nordrhein, 50935, Germany

  • St. Elisabethen Krankenhaus

    Loerrach, Baden-Wurttemberg, 79539, Germany

  • St. Franziskus-Hospital

    Münster, Nordrhein, 48145, Germany

  • St. Gertrauden Krankenhaus

    Berlin, State of Berlin, 10713, Germany

  • St. Josef-Hospital, BZ Rhein-Sieg

    Troisdorf, Nordrhein, 53840, Germany

  • St. Josefs-Hospital, Frauenklinik

    Wiesbaden, Hesse, 65189, Germany

  • St. Joseph Stift

    Bremen, Free Hanseatic City of Bremen, 28209, Germany

  • St. Marienkrankenhaus, Frauenklinik

    Siegen, Nordrhein, 57072, Germany

  • Stadtkrankenhaus Worms

    Worms, Rhineland-Palatinate, 67550, Germany

  • Städtisches Klinikum

    Görlitz, Saxony, 02828, Germany

  • Städtisches Klinikum Brandenburg

    Brandenburg an der Havel, Brandenburg, 14770, Germany

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76133, Germany

  • Uniklinik Köln

    Cologne, Nordrhein, 50931, Germany

  • Universität Dresden, Frauenklinik

    Dresden, Saxony, 01307, Germany

  • Universität Greifswald, Frauenklinik

    Greifswald, Mecklenburg-Vorpommern, 17475, Germany

  • Universität Halle/Saale, Frauenklinik

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitäts-Frauenklinik

    Rostock, Mecklenburg-Vorpommern, 18059, Germany

  • Universitätsfrauenklinik

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsfrauenklinik Bonn

    Bonn, Nordrhein, 53105, Germany

  • Universitätsfrauenklinik Salzburg

    Salzburg, State of Salzburg, 5020, Austria

  • Universitätsfrauenklinik Ulm

    Ulm, Baden-Wurttemberg, 89075, Germany

  • Universitätsklinikum Brustzentrum

    Frankfurt am Main, Hesse, 60590, Germany

  • Universitätsklinikum Essen Frauenklinik

    Essen, Nordrhein, 45122, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Hamburg, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Leipzig, Brustzentrum

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster

    Münster, Nordrhein, 48149, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsklinikum Schleswig-Hostein

    Kiel, Schleswig-Holstein, 24105, Germany

  • ViDia Christliche Kliniken, Diakonissenkrankenhaus Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76199, Germany

  • Vinzenzkrankenhaus Hannover

    Hanover, Lower Saxony, 30559, Germany

  • Westpfalz Klinikum

    Kaiserslautern, Rhineland-Palatinate, 67655, Germany

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