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Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery (INSEMA)

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
no axillary surgery versus SLNB
SLNB versus completion ALND
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring axillary surgery, sentinel lymph node biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • BGZ Dornbirn, Gynäkologie
  • LKH Uni-Klinikum Graz, Gynäkologie
  • Ordensklinikum-BHS
  • Kepler Universitätsklinikum
  • Universitätsfrauenklinik Salzburg
  • KH der Barmherzigen Brüder
  • Hanusch-Krankenhaus, Brustzentrum
  • Landes-Krankenhaus Wolfsberg, Chirurgie
  • Städtisches Klinikum Brandenburg
  • Carl-Thiem-Klinikum
  • Ev. Krankenhaus, Frauenklinik
  • Klinikum Ernst von Bergmann
  • Helios Klinikum, Klinik für Gynäkologie
  • Charite Campus Mitte
  • Sana Klinikum Berlin-Lichtenberg
  • St. Gertrauden Krankenhaus
  • DRK Kliniken Köpenick
  • Park-Klinik Weißensee
  • Evang. Waldkrankenhaus Spandau
  • DRK-Kliniken Westend
  • Krankenhaus Waldfriede
  • Ostalb-Klinikum, Brustzentrum Aalen
  • Caritas-Krankenhaus Brustzentrum Tauberfranken
  • Klinikum Mittelbach Brustzentrum
  • Sana-Klinikum Biberach
  • Krankenhaus Bietigheim
  • Fürst-Stirum-Klinik
  • Klinikum Böblingen
  • Brustzentrum Donau-Riß
  • Klinikum Esslingen
  • Universitätsklinikum Freiburg
  • Frauenklinik Freudenstadt
  • Universitätsklinikum Heidelberg
  • Städtisches Klinikum Karlsruhe
  • ViDia Christliche Kliniken, Diakonissenkrankenhaus Karlsruhe
  • Klinikum Ludwigsburg
  • St. Elisabethen Krankenhaus
  • Helios Klinik Pforzheim
  • Siloah St. Trudpert Klinikum
  • Klinikum am Steinenberg
  • Helios Klinik Rottweil
  • Rems-Murr Klinik
  • Klinikum Tuttlingen
  • Universitätsfrauenklinik
  • Universitätsfrauenklinik Ulm
  • Schwarzwald-Baar Klinikum
  • Rems-Murr Kliniken
  • Klinikum St. Marien
  • AN regiomed Klinikum Ansbach
  • Klinikum Aschaffenburg
  • Hämatologisch-onkologische Praxis
  • Klinikum Bayreuth GmbH, Frauenklinik
  • Kreisklinik Ebersberg
  • Gynäkologische Praxis
  • Klinikum Fürth
  • Klinikum Kempten-Oberallgäu
  • Klinikum Landshut
  • Klinikum Fichtelgebirge gGmbH, Brustzentrum
  • Klinikum Memmingen
  • Klinikum der Universität München
  • Klinikum Harlaching, Frauenklinik
  • Klinikum Passau
  • Frauenklinik der Universität Regensburg, Caritas-Krankenhaus St. Josef
  • Klinikum Starnberg
  • Klinikum Traunstein
  • Kliniken Nordoberpfalz AG, Brustzentrum Weiden
  • Rotkreuzklinik Würzburg
  • Klinikum Mitte, Missio Brustzentrum
  • St. Joseph Stift
  • DIAKO Krankenhaus Bremen
  • Klinikum Frankfurt Höchst
  • Agaplesion Markus Krankenhaus
  • Universitätsklinikum Brustzentrum
  • Main-Kinzig-Kliniken Gelnhausen
  • Klinikum Hanau GmbH
  • Kreiskrankenhaus Bergstraße gGmbH
  • Elisabeth Krankenhaus Kassel
  • Klinikum Kassel
  • Sana Klinikum Offenbach
  • St. Josefs-Hospital, Frauenklinik
  • Asklepios Paulinenklinik
  • Helios Dr. Horst Schmidt Klinikum
  • Universitätsklinikum Hamburg, Brustzentrum
  • Agaplesion Diakonieklinikum, Brustzentrum
  • Gynäkologische Praxisklinik Harburg
  • Albertinen-Krankenhaus, Brustzentrum
  • Universität Greifswald, Frauenklinik
  • Dietrich Bonhoeffer Klinikum, Brustzentrum
  • Universitäts-Frauenklinik
  • Helios Kliniken Schwerin
  • AKH Celle, Brustzentrum
  • Franziskus Hospital Harderberg
  • Helios Klinikum Gifhorn
  • Henriettenstiftung Frauenklinik
  • Vinzenzkrankenhaus Hannover
  • MHH Frauenklinik
  • St. Bernward Krankenhaus
  • Bonifatius-Hospital, Brustzentrum
  • Euregio-Klinik Brustzentrum Nordhorn
  • Agaplesion Ev. Klinikum, Brustzentrum Schaumburg
  • Klinikum Osnabrück
  • Diakoniekrankenhaus, Frauenklinik
  • Klinikum Wolfsburg, Frauenklinik
  • Augusta-Klinik
  • Universitätsfrauenklinik Bonn
  • Marienhospital Bottrop
  • Frauenklinik der H.-Heine-Universität
  • Universitätsklinikum Essen Frauenklinik
  • Kliniken Essen-Mitte
  • Uniklinik Köln
  • St. Elisabeth Krankenhaus, Brustzentrum
  • Klinikum Märkische Kliniken, Brustzentrum
  • Klinikum Lünen, Brustzentrum
  • St. Franziskus-Hospital
  • Universitätsklinikum Münster
  • Marienkrankenhaus
  • St. Marienkrankenhaus, Frauenklinik
  • St. Josef-Hospital, BZ Rhein-Sieg
  • Katharinen-Hospital, Brustzentrum
  • Marien-Hospital
  • Westpfalz Klinikum
  • BZ Mittelrhein Koblenz+Mayen
  • Klinikum Ludwigshafen
  • Diakonissen-Stiftungs-Krankenhaus Speyer
  • Stadtkrankenhaus Worms
  • Universität Halle/Saale, Frauenklinik
  • Krankenhaus St. Elisabeth und St. Barbara
  • Klinik St. Marienstift
  • Altmark-Klinikum Brustzentrum
  • Johanniter-Krankenhaus, Frauenklinik
  • Harzklinikum, Brustzentrum Harz
  • Sana-Klinik
  • DIAKO Diakonissenkrankenhaus
  • Universitätsklinikum Schleswig-Hostein
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Brustzentrum Nordsachsen
  • Diakonissenkrankenhaus
  • Krankenhaus St. Joseph-Stift
  • Universität Dresden, Frauenklinik
  • Städtisches Klinikum
  • Universitätsklinikum Leipzig, Brustzentrum
  • St. Elisabeth Krankenhaus
  • Klinikum Obergöltzsch Rodewisch
  • Helios Klinik
  • Hufeland-Klinik Bad Langensalza
  • SRH Waldklinikum
  • Universitätsklinikum Jena
  • Helios Klinikum Meiningen, Brustzentrum
  • SRH Zentralklinikum Suhl
  • DRK Krankenhaus, Brustzentrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

no axillary surgery

sentinel lymph node biopsy

sentinel lymph node biopsy alone

completion axillary lymph node dissection

Arm Description

standard arm in first randomization

standard arm in second randomization

Outcomes

Primary Outcome Measures

invasive disease-free survival (IDFS) after breast-conserving surgery
non-inferiority question

Secondary Outcome Measures

Full Information

First Posted
June 4, 2015
Last Updated
December 16, 2022
Sponsor
University of Rostock
Collaborators
German Cancer Aid, German Breast Group
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1. Study Identification

Unique Protocol Identification Number
NCT02466737
Brief Title
Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery
Acronym
INSEMA
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
Collaborators
German Cancer Aid, German Breast Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
axillary surgery, sentinel lymph node biopsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
5505 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no axillary surgery
Arm Type
Experimental
Arm Title
sentinel lymph node biopsy
Arm Type
Active Comparator
Arm Description
standard arm in first randomization
Arm Title
sentinel lymph node biopsy alone
Arm Type
Experimental
Arm Title
completion axillary lymph node dissection
Arm Type
Active Comparator
Arm Description
standard arm in second randomization
Intervention Type
Procedure
Intervention Name(s)
no axillary surgery versus SLNB
Intervention Description
in cases with newly diagnosed breast cancer and clinically negative axillary status
Intervention Type
Procedure
Intervention Name(s)
SLNB versus completion ALND
Intervention Description
in cases with 1-3 macrometastases in sentinel lymph nodes
Primary Outcome Measure Information:
Title
invasive disease-free survival (IDFS) after breast-conserving surgery
Description
non-inferiority question
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toralf Reimer, MD, PhD
Organizational Affiliation
University Medicine Rostock
Official's Role
Study Chair
Facility Information:
Facility Name
BGZ Dornbirn, Gynäkologie
City
Dornbirn
ZIP/Postal Code
6850
Country
Austria
Facility Name
LKH Uni-Klinikum Graz, Gynäkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum-BHS
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Kepler Universitätsklinikum
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Universitätsfrauenklinik Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
KH der Barmherzigen Brüder
City
St. Veit/Glan
ZIP/Postal Code
9300
Country
Austria
Facility Name
Hanusch-Krankenhaus, Brustzentrum
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Landes-Krankenhaus Wolfsberg, Chirurgie
City
Wolfsberg
ZIP/Postal Code
9400
Country
Austria
Facility Name
Städtisches Klinikum Brandenburg
City
Brandenburg
State/Province
BB
ZIP/Postal Code
14770
Country
Germany
Facility Name
Carl-Thiem-Klinikum
City
Cottbus
State/Province
BB
ZIP/Postal Code
03046
Country
Germany
Facility Name
Ev. Krankenhaus, Frauenklinik
City
Ludwigsfelde
State/Province
BB
ZIP/Postal Code
14974
Country
Germany
Facility Name
Klinikum Ernst von Bergmann
City
Potsdam
State/Province
BB
ZIP/Postal Code
14467
Country
Germany
Facility Name
Helios Klinikum, Klinik für Gynäkologie
City
Berlin-Buch
State/Province
BE
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite Campus Mitte
City
Berlin
State/Province
BE
ZIP/Postal Code
10117
Country
Germany
Facility Name
Sana Klinikum Berlin-Lichtenberg
City
Berlin
State/Province
BE
ZIP/Postal Code
10365
Country
Germany
Facility Name
St. Gertrauden Krankenhaus
City
Berlin
State/Province
BE
ZIP/Postal Code
10713
Country
Germany
Facility Name
DRK Kliniken Köpenick
City
Berlin
State/Province
BE
ZIP/Postal Code
12559
Country
Germany
Facility Name
Park-Klinik Weißensee
City
Berlin
State/Province
BE
ZIP/Postal Code
13086
Country
Germany
Facility Name
Evang. Waldkrankenhaus Spandau
City
Berlin
State/Province
BE
ZIP/Postal Code
13589
Country
Germany
Facility Name
DRK-Kliniken Westend
City
Berlin
State/Province
BE
ZIP/Postal Code
14050
Country
Germany
Facility Name
Krankenhaus Waldfriede
City
Berlin
State/Province
BE
ZIP/Postal Code
14163
Country
Germany
Facility Name
Ostalb-Klinikum, Brustzentrum Aalen
City
Aalen
State/Province
BW
ZIP/Postal Code
73430
Country
Germany
Facility Name
Caritas-Krankenhaus Brustzentrum Tauberfranken
City
Bad Mergentheim
State/Province
BW
ZIP/Postal Code
97980
Country
Germany
Facility Name
Klinikum Mittelbach Brustzentrum
City
Baden-Baden
State/Province
BW
ZIP/Postal Code
76532
Country
Germany
Facility Name
Sana-Klinikum Biberach
City
Biberach
State/Province
BW
ZIP/Postal Code
88400
Country
Germany
Facility Name
Krankenhaus Bietigheim
City
Bietigheim
State/Province
BW
ZIP/Postal Code
74321
Country
Germany
Facility Name
Fürst-Stirum-Klinik
City
Bruchsal
State/Province
BW
ZIP/Postal Code
76646
Country
Germany
Facility Name
Klinikum Böblingen
City
Böblingen
State/Province
BW
ZIP/Postal Code
71032
Country
Germany
Facility Name
Brustzentrum Donau-Riß
City
Ehingen
State/Province
BW
ZIP/Postal Code
89584
Country
Germany
Facility Name
Klinikum Esslingen
City
Esslingen
State/Province
BW
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
BW
ZIP/Postal Code
79106
Country
Germany
Facility Name
Frauenklinik Freudenstadt
City
Freudenstadt
State/Province
BW
ZIP/Postal Code
72250
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
BW
ZIP/Postal Code
69120
Country
Germany
Facility Name
Städtisches Klinikum Karlsruhe
City
Karlsruhe
State/Province
BW
ZIP/Postal Code
76133
Country
Germany
Facility Name
ViDia Christliche Kliniken, Diakonissenkrankenhaus Karlsruhe
City
Karlsruhe
State/Province
BW
ZIP/Postal Code
76199
Country
Germany
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
State/Province
BW
ZIP/Postal Code
71640
Country
Germany
Facility Name
St. Elisabethen Krankenhaus
City
Lörrach
State/Province
BW
ZIP/Postal Code
79539
Country
Germany
Facility Name
Helios Klinik Pforzheim
City
Pforzheim
State/Province
BW
ZIP/Postal Code
75175
Country
Germany
Facility Name
Siloah St. Trudpert Klinikum
City
Pforzheim
State/Province
BW
ZIP/Postal Code
75179
Country
Germany
Facility Name
Klinikum am Steinenberg
City
Reutlingen
State/Province
BW
ZIP/Postal Code
72764
Country
Germany
Facility Name
Helios Klinik Rottweil
City
Rottweil
State/Province
BW
ZIP/Postal Code
78628
Country
Germany
Facility Name
Rems-Murr Klinik
City
Schorndorf
State/Province
BW
ZIP/Postal Code
73614
Country
Germany
Facility Name
Klinikum Tuttlingen
City
Tuttlingen
State/Province
BW
ZIP/Postal Code
78532
Country
Germany
Facility Name
Universitätsfrauenklinik
City
Tübingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsfrauenklinik Ulm
City
Ulm
State/Province
BW
ZIP/Postal Code
89075
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum
City
Villingen-Schwenningen
State/Province
BW
ZIP/Postal Code
78050
Country
Germany
Facility Name
Rems-Murr Kliniken
City
Winnenden
State/Province
BW
ZIP/Postal Code
71364
Country
Germany
Facility Name
Klinikum St. Marien
City
Amberg
State/Province
BY
ZIP/Postal Code
92224
Country
Germany
Facility Name
AN regiomed Klinikum Ansbach
City
Ansbach
State/Province
BY
ZIP/Postal Code
91522
Country
Germany
Facility Name
Klinikum Aschaffenburg
City
Aschaffenburg
State/Province
BY
ZIP/Postal Code
63739
Country
Germany
Facility Name
Hämatologisch-onkologische Praxis
City
Augsburg
State/Province
BY
ZIP/Postal Code
86150
Country
Germany
Facility Name
Klinikum Bayreuth GmbH, Frauenklinik
City
Bayreuth
State/Province
BY
ZIP/Postal Code
95445
Country
Germany
Facility Name
Kreisklinik Ebersberg
City
Ebersberg
State/Province
BY
ZIP/Postal Code
85560
Country
Germany
Facility Name
Gynäkologische Praxis
City
Eggenfelden
State/Province
BY
ZIP/Postal Code
84307
Country
Germany
Facility Name
Klinikum Fürth
City
Fürth
State/Province
BY
ZIP/Postal Code
90766
Country
Germany
Facility Name
Klinikum Kempten-Oberallgäu
City
Kempten
State/Province
BY
ZIP/Postal Code
87439
Country
Germany
Facility Name
Klinikum Landshut
City
Landshut
State/Province
BY
ZIP/Postal Code
84034
Country
Germany
Facility Name
Klinikum Fichtelgebirge gGmbH, Brustzentrum
City
Marktredwitz
State/Province
BY
ZIP/Postal Code
95615
Country
Germany
Facility Name
Klinikum Memmingen
City
Memmingen
State/Province
BY
ZIP/Postal Code
87700
Country
Germany
Facility Name
Klinikum der Universität München
City
München
State/Province
BY
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinikum Harlaching, Frauenklinik
City
München
State/Province
BY
ZIP/Postal Code
81545
Country
Germany
Facility Name
Klinikum Passau
City
Passau
State/Province
BY
ZIP/Postal Code
94032
Country
Germany
Facility Name
Frauenklinik der Universität Regensburg, Caritas-Krankenhaus St. Josef
City
Regensburg
State/Province
BY
ZIP/Postal Code
93053
Country
Germany
Facility Name
Klinikum Starnberg
City
Starnberg
State/Province
BY
ZIP/Postal Code
82319
Country
Germany
Facility Name
Klinikum Traunstein
City
Traunstein
State/Province
BY
ZIP/Postal Code
83278
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG, Brustzentrum Weiden
City
Weiden
State/Province
BY
ZIP/Postal Code
92637
Country
Germany
Facility Name
Rotkreuzklinik Würzburg
City
Würzburg
State/Province
BY
ZIP/Postal Code
97070
Country
Germany
Facility Name
Klinikum Mitte, Missio Brustzentrum
City
Würzburg
State/Province
BY
ZIP/Postal Code
97074
Country
Germany
Facility Name
St. Joseph Stift
City
Bremen
State/Province
HB
ZIP/Postal Code
28209
Country
Germany
Facility Name
DIAKO Krankenhaus Bremen
City
Bremen
State/Province
HB
ZIP/Postal Code
28239
Country
Germany
Facility Name
Klinikum Frankfurt Höchst
City
Frankfurt am Main
State/Province
HE
ZIP/Postal Code
65929
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt
State/Province
HE
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitätsklinikum Brustzentrum
City
Frankfurt
State/Province
HE
ZIP/Postal Code
60590
Country
Germany
Facility Name
Main-Kinzig-Kliniken Gelnhausen
City
Gelnhausen
State/Province
HE
ZIP/Postal Code
63571
Country
Germany
Facility Name
Klinikum Hanau GmbH
City
Hanau
State/Province
HE
ZIP/Postal Code
63450
Country
Germany
Facility Name
Kreiskrankenhaus Bergstraße gGmbH
City
Heppenheim
State/Province
HE
ZIP/Postal Code
64646
Country
Germany
Facility Name
Elisabeth Krankenhaus Kassel
City
Kassel
State/Province
HE
ZIP/Postal Code
34117
Country
Germany
Facility Name
Klinikum Kassel
City
Kassel
State/Province
HE
ZIP/Postal Code
34125
Country
Germany
Facility Name
Sana Klinikum Offenbach
City
Offenbach
State/Province
HE
ZIP/Postal Code
63069
Country
Germany
Facility Name
St. Josefs-Hospital, Frauenklinik
City
Wiesbaden
State/Province
HE
ZIP/Postal Code
65189
Country
Germany
Facility Name
Asklepios Paulinenklinik
City
Wiesbaden
State/Province
HE
ZIP/Postal Code
65197
Country
Germany
Facility Name
Helios Dr. Horst Schmidt Klinikum
City
Wiesbaden
State/Province
HE
ZIP/Postal Code
65199
Country
Germany
Facility Name
Universitätsklinikum Hamburg, Brustzentrum
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany
Facility Name
Agaplesion Diakonieklinikum, Brustzentrum
City
Hamburg
State/Province
HH
ZIP/Postal Code
20259
Country
Germany
Facility Name
Gynäkologische Praxisklinik Harburg
City
Hamburg
State/Province
HH
ZIP/Postal Code
21673
Country
Germany
Facility Name
Albertinen-Krankenhaus, Brustzentrum
City
Hamburg
State/Province
HH
ZIP/Postal Code
22457
Country
Germany
Facility Name
Universität Greifswald, Frauenklinik
City
Greifswald
State/Province
MV
ZIP/Postal Code
17475
Country
Germany
Facility Name
Dietrich Bonhoeffer Klinikum, Brustzentrum
City
Neubrandenburg
State/Province
MV
ZIP/Postal Code
17036
Country
Germany
Facility Name
Universitäts-Frauenklinik
City
Rostock
State/Province
MV
ZIP/Postal Code
18059
Country
Germany
Facility Name
Helios Kliniken Schwerin
City
Schwerin
State/Province
MV
ZIP/Postal Code
19049
Country
Germany
Facility Name
AKH Celle, Brustzentrum
City
Celle
State/Province
NI
ZIP/Postal Code
29223
Country
Germany
Facility Name
Franziskus Hospital Harderberg
City
Georgsmarienhütte
State/Province
NI
ZIP/Postal Code
49124
Country
Germany
Facility Name
Helios Klinikum Gifhorn
City
Gifhorn
State/Province
NI
ZIP/Postal Code
38518
Country
Germany
Facility Name
Henriettenstiftung Frauenklinik
City
Hannover
State/Province
NI
ZIP/Postal Code
30559
Country
Germany
Facility Name
Vinzenzkrankenhaus Hannover
City
Hannover
State/Province
NI
ZIP/Postal Code
30559
Country
Germany
Facility Name
MHH Frauenklinik
City
Hannover
State/Province
NI
ZIP/Postal Code
30625
Country
Germany
Facility Name
St. Bernward Krankenhaus
City
Hildesheim
State/Province
NI
ZIP/Postal Code
31134
Country
Germany
Facility Name
Bonifatius-Hospital, Brustzentrum
City
Lingen
State/Province
NI
ZIP/Postal Code
49808
Country
Germany
Facility Name
Euregio-Klinik Brustzentrum Nordhorn
City
Nordhorn
State/Province
NI
ZIP/Postal Code
48527
Country
Germany
Facility Name
Agaplesion Ev. Klinikum, Brustzentrum Schaumburg
City
Obernkirchen
State/Province
NI
ZIP/Postal Code
31683
Country
Germany
Facility Name
Klinikum Osnabrück
City
Osnabrück
State/Province
NI
ZIP/Postal Code
49076
Country
Germany
Facility Name
Diakoniekrankenhaus, Frauenklinik
City
Rotenburg
State/Province
NI
ZIP/Postal Code
27356
Country
Germany
Facility Name
Klinikum Wolfsburg, Frauenklinik
City
Wolfsburg
State/Province
NI
ZIP/Postal Code
38440
Country
Germany
Facility Name
Augusta-Klinik
City
Bochum
State/Province
Nordrhein
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsfrauenklinik Bonn
City
Bonn
State/Province
Nordrhein
ZIP/Postal Code
53105
Country
Germany
Facility Name
Marienhospital Bottrop
City
Bottrop
State/Province
Nordrhein
ZIP/Postal Code
46236
Country
Germany
Facility Name
Frauenklinik der H.-Heine-Universität
City
Düsseldorf
State/Province
Nordrhein
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitätsklinikum Essen Frauenklinik
City
Essen
State/Province
Nordrhein
ZIP/Postal Code
45122
Country
Germany
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
Nordrhein
ZIP/Postal Code
45136
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
State/Province
Nordrhein
ZIP/Postal Code
50931
Country
Germany
Facility Name
St. Elisabeth Krankenhaus, Brustzentrum
City
Köln
State/Province
Nordrhein
ZIP/Postal Code
50935
Country
Germany
Facility Name
Klinikum Märkische Kliniken, Brustzentrum
City
Lüdenscheid
State/Province
Nordrhein
ZIP/Postal Code
58515
Country
Germany
Facility Name
Klinikum Lünen, Brustzentrum
City
Lünen
State/Province
Nordrhein
ZIP/Postal Code
44534
Country
Germany
Facility Name
St. Franziskus-Hospital
City
Münster
State/Province
Nordrhein
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein
ZIP/Postal Code
48149
Country
Germany
Facility Name
Marienkrankenhaus
City
Schwerte
State/Province
Nordrhein
ZIP/Postal Code
58239
Country
Germany
Facility Name
St. Marienkrankenhaus, Frauenklinik
City
Siegen
State/Province
Nordrhein
ZIP/Postal Code
57072
Country
Germany
Facility Name
St. Josef-Hospital, BZ Rhein-Sieg
City
Troisdorf
State/Province
Nordrhein
ZIP/Postal Code
53840
Country
Germany
Facility Name
Katharinen-Hospital, Brustzentrum
City
Unna
State/Province
Nordrhein
ZIP/Postal Code
59423
Country
Germany
Facility Name
Marien-Hospital
City
Wesel
State/Province
Nordrhein
ZIP/Postal Code
46483
Country
Germany
Facility Name
Westpfalz Klinikum
City
Kaiserslautern
State/Province
RP
ZIP/Postal Code
67655
Country
Germany
Facility Name
BZ Mittelrhein Koblenz+Mayen
City
Koblenz
State/Province
RP
ZIP/Postal Code
56073
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
State/Province
RP
ZIP/Postal Code
67063
Country
Germany
Facility Name
Diakonissen-Stiftungs-Krankenhaus Speyer
City
Speyer
State/Province
RP
ZIP/Postal Code
67346
Country
Germany
Facility Name
Stadtkrankenhaus Worms
City
Worms
State/Province
RP
ZIP/Postal Code
67550
Country
Germany
Facility Name
Universität Halle/Saale, Frauenklinik
City
Halle/Saale
State/Province
Saint
ZIP/Postal Code
06120
Country
Germany
Facility Name
Krankenhaus St. Elisabeth und St. Barbara
City
Halle
State/Province
Saint
ZIP/Postal Code
06110
Country
Germany
Facility Name
Klinik St. Marienstift
City
Magdeburg
State/Province
Saint
ZIP/Postal Code
39110
Country
Germany
Facility Name
Altmark-Klinikum Brustzentrum
City
Salzwedel
State/Province
Saint
ZIP/Postal Code
29410
Country
Germany
Facility Name
Johanniter-Krankenhaus, Frauenklinik
City
Stendal
State/Province
Saint
ZIP/Postal Code
39576
Country
Germany
Facility Name
Harzklinikum, Brustzentrum Harz
City
Wernigerode
State/Province
Saint
ZIP/Postal Code
38855
Country
Germany
Facility Name
Sana-Klinik
City
Eutin
State/Province
SH
ZIP/Postal Code
23701
Country
Germany
Facility Name
DIAKO Diakonissenkrankenhaus
City
Flensburg
State/Province
SH
ZIP/Postal Code
24939
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Hostein
City
Kiel
State/Province
SH
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
State/Province
SH
ZIP/Postal Code
23538
Country
Germany
Facility Name
Brustzentrum Nordsachsen
City
Borna
State/Province
SN
ZIP/Postal Code
04552
Country
Germany
Facility Name
Diakonissenkrankenhaus
City
Dresden
State/Province
SN
ZIP/Postal Code
01099
Country
Germany
Facility Name
Krankenhaus St. Joseph-Stift
City
Dresden
State/Province
SN
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universität Dresden, Frauenklinik
City
Dresden
State/Province
SN
ZIP/Postal Code
01307
Country
Germany
Facility Name
Städtisches Klinikum
City
Görlitz
State/Province
SN
ZIP/Postal Code
02828
Country
Germany
Facility Name
Universitätsklinikum Leipzig, Brustzentrum
City
Leipzig
State/Province
SN
ZIP/Postal Code
04103
Country
Germany
Facility Name
St. Elisabeth Krankenhaus
City
Leipzig
State/Province
SN
ZIP/Postal Code
04277
Country
Germany
Facility Name
Klinikum Obergöltzsch Rodewisch
City
Rodewisch
State/Province
SN
ZIP/Postal Code
08228
Country
Germany
Facility Name
Helios Klinik
City
Schkeuditz
State/Province
SN
ZIP/Postal Code
04435
Country
Germany
Facility Name
Hufeland-Klinik Bad Langensalza
City
Bad Langensalza
State/Province
TH
ZIP/Postal Code
99947
Country
Germany
Facility Name
SRH Waldklinikum
City
Gera
State/Province
TH
ZIP/Postal Code
07548
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
TH
ZIP/Postal Code
07747
Country
Germany
Facility Name
Helios Klinikum Meiningen, Brustzentrum
City
Meiningen
State/Province
TH
ZIP/Postal Code
98617
Country
Germany
Facility Name
SRH Zentralklinikum Suhl
City
Suhl
State/Province
TH
ZIP/Postal Code
98527
Country
Germany
Facility Name
DRK Krankenhaus, Brustzentrum
City
Sömmerda
State/Province
TH
ZIP/Postal Code
99610
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28331237
Citation
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.
Results Reference
result
PubMed Identifier
32437921
Citation
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.
Results Reference
result
PubMed Identifier
36457648
Citation
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.
Results Reference
result

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Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery

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