AzTrials
AzTrials

Breast CancerINSEMANCT02466737

Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

A study testing no axillary surgery versus SLNB and SLNB versus completion ALND in people with Breast Cancer, run by University of Rostock at 150 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
no axillary surgery versus SLNB and SLNB versus completion ALND
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,505 participants
Where
150 sitesin 2 countries
Study dates
Sep 2015to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

150 sites in 2 countries.

150 sites in 2 countries

Germany142 sites

  • Ostalb-Klinikum, Brustzentrum Aalen

    Aalen, Baden-Wurttemberg, 73430

  • Klinikum St. Marien

    Amberg, Bavaria, 92224

  • AN regiomed Klinikum Ansbach

    Ansbach, Bavaria, 91522

  • Klinikum Aschaffenburg

    Aschaffenburg, Bavaria, 63739

  • Hämatologisch-onkologische Praxis

    Augsburg, Bavaria, 86150

  • Hufeland-Klinik Bad Langensalza

    Bad Langensalza, Thuringia, 99947

  • Caritas-Krankenhaus Brustzentrum Tauberfranken

    Bad Mergentheim, Baden-Wurttemberg, 97980

  • Klinikum Mittelbach Brustzentrum

    Baden-Baden, Baden-Wurttemberg, 76532

  • Klinikum Bayreuth GmbH, Frauenklinik

    Bayreuth, Bavaria, 95445

  • Charite Campus Mitte

    Berlin, State of Berlin, 10117

  • Sana Klinikum Berlin-Lichtenberg

    Berlin, State of Berlin, 10365

  • St. Gertrauden Krankenhaus

    Berlin, State of Berlin, 10713

  • DRK Kliniken Köpenick

    Berlin, State of Berlin, 12559

  • Park-Klinik Weißensee

    Berlin, State of Berlin, 13086

  • Evang. Waldkrankenhaus Spandau

    Berlin, State of Berlin, 13589

  • DRK-Kliniken Westend

    Berlin, State of Berlin, 14050

  • Krankenhaus Waldfriede

    Berlin, State of Berlin, 14163

  • Sana-Klinikum Biberach

    Biberach, Baden-Wurttemberg, 88400

  • Krankenhaus Bietigheim

    Bietigheim, Baden-Wurttemberg, 74321

  • Klinikum Böblingen

    Böblingen, Baden-Wurttemberg, 71032

  • Augusta-Klinik

    Bochum, Nordrhein, 44791

  • Universitätsfrauenklinik Bonn

    Bonn, Nordrhein, 53105

  • Brustzentrum Nordsachsen

    Borna, Saxony, 04552

  • Marienhospital Bottrop

    Bottrop, Nordrhein, 46236

  • Städtisches Klinikum Brandenburg

    Brandenburg an der Havel, Brandenburg, 14770

  • St. Joseph Stift

    Bremen, Free Hanseatic City of Bremen, 28209

  • DIAKO Krankenhaus Bremen

    Bremen, Free Hanseatic City of Bremen, 28239

  • Fürst-Stirum-Klinik

    Bruchsal, Baden-Wurttemberg, 76646

  • Helios Klinikum, Klinik für Gynäkologie

    Buch, State of Berlin, 13125

  • AKH Celle, Brustzentrum

    Celle, Lower Saxony, 29223

  • Uniklinik Köln

    Cologne, Nordrhein, 50931

  • St. Elisabeth Krankenhaus, Brustzentrum

    Cologne, Nordrhein, 50935

  • Carl-Thiem-Klinikum

    Cottbus, Brandenburg, 03046

  • Diakonissenkrankenhaus

    Dresden, Saxony, 01099

  • Krankenhaus St. Joseph-Stift

    Dresden, Saxony, 01307

  • Universität Dresden, Frauenklinik

    Dresden, Saxony, 01307

  • Frauenklinik der H.-Heine-Universität

    Düsseldorf, Nordrhein, 40225

  • Kreisklinik Ebersberg

    Ebersberg, Bavaria, 85560

  • Gynäkologische Praxis

    Eggenfelden, Bavaria, 84307

  • Brustzentrum Donau-Riß

    Ehingen, Baden-Wurttemberg, 89584

  • Universitätsklinikum Essen Frauenklinik

    Essen, Nordrhein, 45122

  • Kliniken Essen-Mitte

    Essen, Nordrhein, 45136

  • Klinikum Esslingen

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Sana-Klinik

    Eutin, Schleswig-Holstein, 23701

  • DIAKO Diakonissenkrankenhaus

    Flensburg, Schleswig-Holstein, 24939

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431

  • Universitätsklinikum Brustzentrum

    Frankfurt am Main, Hesse, 60590

  • Klinikum Frankfurt Höchst

    Frankfurt am Main, Hesse, 65929

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Frauenklinik Freudenstadt

    Freudenstadt, Baden-Wurttemberg, 72250

  • Klinikum Fürth

    Fürth, Bavaria, 90766

  • Main-Kinzig-Kliniken Gelnhausen

    Gelnhausen, Hesse, 63571

  • Franziskus Hospital Harderberg

    Georgsmarienhütte, Lower Saxony, 49124

  • SRH Waldklinikum

    Gera, Thuringia, 07548

  • Helios Klinikum Gifhorn

    Gifhorn, Lower Saxony, 38518

  • Städtisches Klinikum

    Görlitz, Saxony, 02828

  • Universität Greifswald, Frauenklinik

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, Saxony-Anhalt, 06110

  • Universität Halle/Saale, Frauenklinik

    Halle, Saxony-Anhalt, 06120

  • Universitätsklinikum Hamburg, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Agaplesion Diakonieklinikum, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 20259

  • Gynäkologische Praxisklinik Harburg

    Hamburg, Free and Hanseatic City of Hamburg, 21673

  • Albertinen-Krankenhaus, Brustzentrum

    Hamburg, Free and Hanseatic City of Hamburg, 22457

  • Klinikum Hanau GmbH

    Hanau, Hesse, 63450

  • Henriettenstiftung Frauenklinik

    Hanover, Lower Saxony, 30559

  • Vinzenzkrankenhaus Hannover

    Hanover, Lower Saxony, 30559

  • MHH Frauenklinik

    Hanover, Lower Saxony, 30625

  • Altmark-Klinikum Brustzentrum

    Hansestadt Salzwedel, Saxony-Anhalt, 29410

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Kreiskrankenhaus Bergstraße gGmbH

    Heppenheim an der Bergstrasse, Hesse, 64646

  • St. Bernward Krankenhaus

    Hildesheim, Lower Saxony, 31134

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • Westpfalz Klinikum

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76133

  • ViDia Christliche Kliniken, Diakonissenkrankenhaus Karlsruhe

    Karlsruhe, Baden-Wurttemberg, 76199

  • Elisabeth Krankenhaus Kassel

    Kassel, Hesse, 34117

  • Klinikum Kassel

    Kassel, Hesse, 34125

  • Klinikum Kempten-Oberallgäu

    Kempten (Allgäu), Bavaria, 87439

  • Universitätsklinikum Schleswig-Hostein

    Kiel, Schleswig-Holstein, 24105

  • BZ Mittelrhein Koblenz+Mayen

    Koblenz, Rhineland-Palatinate, 56073

  • Klinikum Landshut

    Landshut, Bavaria, 84034

  • Universitätsklinikum Leipzig, Brustzentrum

    Leipzig, Saxony, 04103

  • St. Elisabeth Krankenhaus

    Leipzig, Saxony, 04277

  • Bonifatius-Hospital, Brustzentrum

    Lingen, Lower Saxony, 49808

  • St. Elisabethen Krankenhaus

    Loerrach, Baden-Wurttemberg, 79539

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538

  • Klinikum Märkische Kliniken, Brustzentrum

    Lüdenscheid, Nordrhein, 58515

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Ev. Krankenhaus, Frauenklinik

    Ludwigsfelde, Brandenburg, 14974

  • Klinikum Ludwigshafen

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • Klinikum Lünen, Brustzentrum

    Lünen, Nordrhein, 44534

  • Klinik St. Marienstift

    Magdeburg, Saxony-Anhalt, 39110

  • Klinikum Fichtelgebirge gGmbH, Brustzentrum

    Marktredwitz, Bavaria, 95615

  • Helios Klinikum Meiningen, Brustzentrum

    Meiningen, Thuringia, 98617

  • Klinikum Memmingen

    Memmingen, Bavaria, 87700

  • Klinikum der Universität München

    München, Bavaria, 80337

  • Klinikum Harlaching, Frauenklinik

    München, Bavaria, 81545

  • St. Franziskus-Hospital

    Münster, Nordrhein, 48145

  • Universitätsklinikum Münster

    Münster, Nordrhein, 48149

  • Dietrich Bonhoeffer Klinikum, Brustzentrum

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • Euregio-Klinik Brustzentrum Nordhorn

    Nordhorn, Lower Saxony, 48527

  • Agaplesion Ev. Klinikum, Brustzentrum Schaumburg

    Obernkirchen, Lower Saxony, 31683

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069

  • Klinikum Osnabrück

    Osnabrück, Lower Saxony, 49076

  • Klinikum Passau

    Passau, Bavaria, 94032

  • Helios Klinik Pforzheim

    Pforzheim, Baden-Wurttemberg, 75175

  • Siloah St. Trudpert Klinikum

    Pforzheim, Baden-Wurttemberg, 75179

  • Klinikum Ernst von Bergmann

    Potsdam, Brandenburg, 14467

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

    Regensburg, Bavaria, 93053

  • Klinikum am Steinenberg

    Reutlingen, Baden-Wurttemberg, 72764

  • Klinikum Obergöltzsch Rodewisch

    Rodewisch, Saxony, 08228

  • Universitäts-Frauenklinik

    Rostock, Mecklenburg-Vorpommern, 18059

  • Diakoniekrankenhaus, Frauenklinik

    Rotenburg (Wümme), Lower Saxony, 27356

  • Helios Klinik Rottweil

    Rottweil, Baden-Wurttemberg, 78628

  • Helios Klinik

    Schkeuditz, Saxony, 04435

  • Rems-Murr Klinik

    Schorndorf, Baden-Wurttemberg, 73614

  • Helios Kliniken Schwerin

    Schwerin, Mecklenburg-Vorpommern, 19049

  • Marienkrankenhaus

    Schwerte, Nordrhein, 58239

  • St. Marienkrankenhaus, Frauenklinik

    Siegen, Nordrhein, 57072

  • DRK Krankenhaus, Brustzentrum

    Sömmerda, Thuringia, 99610

  • Diakonissen-Stiftungs-Krankenhaus Speyer

    Speyer, Rhineland-Palatinate, 67346

  • Klinikum Starnberg

    Starnberg, Bavaria, 82319

  • Johanniter-Krankenhaus, Frauenklinik

    Stendal, Saxony-Anhalt, 39576

  • SRH Zentralklinikum Suhl

    Suhl, Thuringia, 98527

  • Klinikum Traunstein

    Traunstein, Bavaria, 83278

  • St. Josef-Hospital, BZ Rhein-Sieg

    Troisdorf, Nordrhein, 53840

  • Universitätsfrauenklinik

    Tübingen, Baden-Wurttemberg, 72076

  • Klinikum Tuttlingen

    Tuttlingen, Baden-Wurttemberg, 78532

  • Universitätsfrauenklinik Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Katharinen-Hospital, Brustzentrum

    Unna, Nordrhein, 59423

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, Baden-Wurttemberg, 78050

  • Kliniken Nordoberpfalz AG, Brustzentrum Weiden

    Weiden, Bavaria, 92637

  • Harzklinikum, Brustzentrum Harz

    Wernigerode, Saxony-Anhalt, 38855

  • Marien-Hospital

    Wesel, Nordrhein, 46483

  • St. Josefs-Hospital, Frauenklinik

    Wiesbaden, Hesse, 65189

  • Asklepios Paulinenklinik

    Wiesbaden, Hesse, 65197

  • Helios Dr. Horst Schmidt Klinikum

    Wiesbaden, Hesse, 65199

  • Rems-Murr Kliniken

    Winnenden, Baden-Wurttemberg, 71364

  • Klinikum Wolfsburg, Frauenklinik

    Wolfsburg, Lower Saxony, 38440

  • Stadtkrankenhaus Worms

    Worms, Rhineland-Palatinate, 67550

  • Rotkreuzklinik Würzburg

    Würzburg, Bavaria, 97070

  • Klinikum Mitte, Missio Brustzentrum

    Würzburg, Bavaria, 97074

Other trials in Germany

Austria8 sites

  • BGZ Dornbirn, Gynäkologie

    Dornbirn, 6850

  • LKH Uni-Klinikum Graz, Gynäkologie

    Graz, 8036

  • Ordensklinikum-BHS

    Linz, 4010

  • Kepler Universitätsklinikum

    Linz, 4020

  • KH der Barmherzigen Brüder

    Saint Veit/Glan, 9300

  • Universitätsfrauenklinik Salzburg

    Salzburg, State of Salzburg, 5020

  • Hanusch-Krankenhaus, Brustzentrum

    Vienna, 1140

  • Landes-Krankenhaus Wolfsberg, Chirurgie

    Wolfsberg, 9400

Other trials in Austria

About this study

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

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.

Read the detailed description

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 (1-3 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).

During follow-up, patients will be assessed for disease recurrence according to standard clinical practice. History and physical examination will be performed every 6 months for the first 36 months and yearly thereafter. Annual mammography and sonography will be required; other testing will be based on symptoms and investigator preference. The total number of patients to be randomized into the trial will be approximately 7,095. An event-driven final efficacy analysis will be performed per-protocol for two primary objectives.

Conditions
Breast Cancer
Being tested
no axillary surgery versus SLNB, SLNB versus completion ALND
Keywords
axillary surgery, sentinel lymph node biopsy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no axillary surgery versus SLNBProcedure or surgery

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

  • SLNB versus completion ALNDProcedure or surgery

    in cases with 1-3 macrometastases in sentinel lymph nodes

Study groups in NCT02466737
Study groupRoleWhat they receive
no axillary surgeryExperimentalNot described
Receives: Procedure: no axillary surgery versus SLNB
sentinel lymph node biopsyActive comparatorstandard arm in first randomization
Receives: Procedure: no axillary surgery versus SLNB
sentinel lymph node biopsy aloneExperimentalNot described
Receives: Procedure: SLNB versus completion ALND
completion axillary lymph node dissectionActive comparatorstandard arm in second randomization
Receives: Procedure: SLNB versus completion ALND

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. invasive disease-free survival (IDFS) after breast-conserving surgery

    non-inferiority question

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion30 Aug 2024
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
5,505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466737
Sponsor's protocol ID
GBG 75 / ABCSG 43
Acronym
INSEMA
Status last verified
Apr 2026
First submitted
4 Jun 2015
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Reimer T, Stachs A, Nekljudova V, Loibl S, Hartmann S, Wolter K, Hildebrandt G, Gerber B. Restricted Axillary Staging in Clinically and Sonographically Node-Negative Early Invasive Breast Cancer (c/iT1-2) in the Context of Breast Conserving Therapy: First Results Following Commencement of the Intergroup-Sentinel-Mamma (INSEMA) Trial. Geburtshilfe Frauenheilkd. 2017 Feb;77(2):149-157. doi: 10.1055/s-0042-122853.

    PubMed 28331237

  • Hildebrandt G, Stachs A, Gerber B, Potenberg J, Krug D, Wolter K, Kuhn T, Zierhut D, Sedlmayer F, Kaiser J, Reitsamer R, Heil J, Nekljudova V, Bekes I, Loibl S, Reimer T. Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):683-693. doi: 10.1016/j.ijrobp.2020.04.042. Epub 2020 May 11.

    PubMed 32437921

  • Reimer T, Stachs A, Veselinovic K, Polata S, Muller T, Kuhn T, Heil J, Ataseven B, Reitsamer R, Hildebrandt G, Knauer M, Golatta M, Stefek A, Zahm DM, Thill M, Nekljudova V, Krug D, Loibl S, Gerber B; INSEMA investigators. Patient-reported outcomes for the Intergroup Sentinel Mamma study (INSEMA): A randomised trial with persistent impact of axillary surgery on arm and breast symptoms in patients with early breast cancer. EClinicalMedicine. 2022 Nov 25;55:101756. doi: 10.1016/j.eclinm.2022.101756. eCollection 2023 Jan.

    PubMed 36457648

  • Marme F, Krieghoff-Henning E, Gerber B, Schmitt M, Zahm DM, Bauerschlag D, Forstbauer H, Hildebrandt G, Ataseven B, Brodkorb T, Denkert C, Stachs A, Krug D, Heil J, Golatta M, Kuhn T, Nekljudova V, Gaiser T, Schonmehl R, Brochhausen C, Loibl S, Reimer T, Brinker TJ. Deep learning to predict breast cancer sentinel lymph node status on INSEMA histological images. Eur J Cancer. 2023 Dec;195:113390. doi: 10.1016/j.ejca.2023.113390. Epub 2023 Oct 18.

    PubMed 37890350

  • Reimer T, Stachs A, Veselinovic K, Kuhn T, Heil J, Polata S, Marme F, Muller T, Hildebrandt G, Krug D, Ataseven B, Reitsamer R, Ruth S, Denkert C, Bekes I, Zahm DM, Thill M, Golatta M, Holtschmidt J, Knauer M, Nekljudova V, Loibl S, Gerber B. Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial. N Engl J Med. 2025 Mar 13;392(11):1051-1064. doi: 10.1056/NEJMoa2412063. Epub 2024 Dec 12.

    PubMed 39665649

  • Reimer T, Stachs A, Veselinovic K, Kuehn T, Heil J, Polata S, Marme F, Trapp E, Hildebrandt G, Krug D, Ataseven B, Reitsamer R, Ruth S, Denkert C, Bekes I, Stahl N, Thill M, Strittmatter HJ, Mueller T, Golatta M, Zahm DM, Holtschmidt J, Knauer M, Nekljudova V, Loibl S, Gerber B. Axillary surgery in patients with sentinel node macrometastases: secondary results of the randomized INSEMA trial. NPJ Breast Cancer. 2026 Jan 27;12(1):19. doi: 10.1038/s41523-026-00902-7.

    PubMed 41593108

Questions about this trial

What is this clinical trial studying?

A study testing no axillary surgery versus SLNB and SLNB versus completion ALND in people with Breast Cancer, run by University of Rostock at 150 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

invasive disease-free survival (IDFS) after breast-conserving surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466737, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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