Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
NCT ID: NCT02240472
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2700 participants
INTERVENTIONAL
2015-01-27
2031-12-31
Brief Summary
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The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.
This study is a prospective international randomized trial including 3500 patients.
Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axillary clearance
Patients in this arm will be treated by completion axillary clearance after a sentinel node biopsy showing 1-2 nodes with macrometastasis
No interventions assigned to this group
No axillary clearance
Patients in this arm will not undergo further axillary surgery after a sentinel node biopsy showing 1-2 nodes with macrometastasis
Omission of axillary clearance
The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis
Interventions
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Omission of axillary clearance
The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis
Eligibility Criteria
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Inclusion Criteria
* N0 on palpation
* Preoperative ultrasound performed
* Pathology report shows macrometastasis in 1-2 sentinel lymph nodes
* Patients undergo breast-conserving therapy or mastectomy
* The patient must have provided oral and written consent
* Age ≥ 18 years
Exclusion Criteria
* Prior history of invasive breast cancer
* Pregnancy
* Medical contraindication for radiotherapy or systemic treatment
* Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
18 Years
ALL
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Swedish Cancer Foundation
OTHER
Nordic Cancer Union
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Jana de Boniface
Associate Professor
Principal Investigators
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Jana de Boniface, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Jan Frisell, Professor
Role: STUDY_CHAIR
Karolinska University Hospital
Leif Bergkvist, Professor
Role: STUDY_CHAIR
Central Hospital Västerås
Yvette Andersson, PhD
Role: STUDY_CHAIR
Central Hospital Västerås
Lisa Ryden, Professor
Role: STUDY_CHAIR
Lund University
Malin Sund, Professor
Role: STUDY_CHAIR
Umeå University Hospital
Olofsson Roger, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Johan Ahlgren, PhD
Role: STUDY_CHAIR
Region Örebro County
Dan Lundstedt, PhD
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Peer Christiansen, Professor
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital, Denmark
Tove Tvedskov Filtenborg, MD
Role: STUDY_CHAIR
Rigshospitalet Copenhagen, Dnmark
Michalis Kontos, PhD
Role: STUDY_CHAIR
University of Athens
Birgitte Offersen, Professor
Role: STUDY_CHAIR
University of Aarhus
Thorsten Kühn, Professor
Role: PRINCIPAL_INVESTIGATOR
Klinikum Esslingen
Toralf Reimer, Professor
Role: PRINCIPAL_INVESTIGATOR
Universität Rostock
Oreste Gentilini
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital, Milano
Roland Reitsamer
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Salzburg
Locations
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Sygehus Sonderjylland
Aabenraa, , Denmark
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Sydvestjysk Sygehus
Esbjerg, , Denmark
Sygehus Lillebaelt
Lillebaelt, , Denmark
Odense University Hospital
Odense, , Denmark
Randers Regionshospitalet
Randers, , Denmark
Regionshospitalet Viborg
Viborg, , Denmark
Athens University Hospital
Athens, , Greece
Gävle sjukhus
Gävle, , Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Hallands sjukhus
Halmstad, , Sweden
Helsingborg lasarett
Helsingborg, , Sweden
Länssjukhuset Ryhov
Jönköping, , Sweden
Kalmar sjukhus
Kalmar, , Sweden
Blekinge sjukhuset
Karlskrona, , Sweden
Karlstad sjukhus
Karlstad, , Sweden
Central Hospital Kristianstad
Kristianstad, , Sweden
Linköping University Hospital
Linköping, , Sweden
Malmö/Lund University Hospital
Lund, , Sweden
Örebro University Hospital
Örebro, , Sweden
Skaraborgs sjukhus
Skövde/Lidköping, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Southern Gerenal Hospital
Stockholm, , Sweden
St. Görans Hospital
Stockholm, , Sweden
Sundsvall länssjukhus
Sundsvall, , Sweden
Uddevalla sjukhus
Uddevalla, , Sweden
Umeå University Hospital
Umeå, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Varbergs sjukhus
Varberg, , Sweden
Västerås Central Hospital
Västerås, , Sweden
Västervik Hospital
Västervik, , Sweden
Countries
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References
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Skarping I, Bendahl PO, Szulkin R, Alkner S, Andersson Y, Bergkvist L, Christiansen P, Filtenborg Tvedskov T, Frisell J, Gentilini OD, Kontos M, Kuhn T, Lundstedt D, Vrou Offersen B, Olofsson Bagge R, Reimer T, Sund M, Ryden L, de Boniface J. Prediction of High Nodal Burden in Patients With Sentinel Node-Positive Luminal ERBB2-Negative Breast Cancer. JAMA Surg. 2024 Dec 1;159(12):1393-1403. doi: 10.1001/jamasurg.2024.3944.
de Boniface J, Appelgren M, Szulkin R, Alkner S, Andersson Y, Bergkvist L, Frisell J, Gentilini OD, Kontos M, Kuhn T, Lundstedt D, Offersen BV, Olofsson Bagge R, Reimer T, Sund M, Christiansen P, Ryden L, Filtenborg Tvedskov T; SENOMAC Trialists' Group. Completion axillary lymph node dissection for the identification of pN2-3 status as an indication for adjuvant CDK4/6 inhibitor treatment: a post-hoc analysis of the randomised, phase 3 SENOMAC trial. Lancet Oncol. 2024 Sep;25(9):1222-1230. doi: 10.1016/S1470-2045(24)00350-4. Epub 2024 Aug 6.
de Boniface J, Filtenborg Tvedskov T, Ryden L, Szulkin R, Reimer T, Kuhn T, Kontos M, Gentilini OD, Olofsson Bagge R, Sund M, Lundstedt D, Appelgren M, Ahlgren J, Norenstedt S, Celebioglu F, Sackey H, Scheel Andersen I, Hoyer U, Nyman PF, Vikhe Patil E, Wieslander E, Dahl Nissen H, Alkner S, Andersson Y, Offersen BV, Bergkvist L, Frisell J, Christiansen P; SENOMAC Trialists' Group; SENOMAC Trialists' Group. Omitting Axillary Dissection in Breast Cancer with Sentinel-Node Metastases. N Engl J Med. 2024 Apr 4;390(13):1163-1175. doi: 10.1056/NEJMoa2313487.
Appelgren M, Sackey H, Wengstrom Y, Johansson K, Ahlgren J, Andersson Y, Bergkvist L, Frisell J, Lundstedt D, Ryden L, Sund M, Alkner S, Vrou Offersen B, Filtenborg Tvedskov T, Christiansen P, de Boniface J; SENOMAC Trialists' Group. Patient-reported outcomes one year after positive sentinel lymph node biopsy with or without axillary lymph node dissection in the randomized SENOMAC trial. Breast. 2022 Jun;63:16-23. doi: 10.1016/j.breast.2022.02.013. Epub 2022 Mar 1.
de Boniface J, Ahlgren J, Andersson Y, Bergkvist L, Frisell J, Lundstedt D, Olofsson Bagge R, Ryden L, Sund M; SENOMAC Trialists' Group. The generalisability of randomised clinical trials: an interim external validity analysis of the ongoing SENOMAC trial in sentinel lymph node-positive breast cancer. Breast Cancer Res Treat. 2020 Feb;180(1):167-176. doi: 10.1007/s10549-020-05537-1. Epub 2020 Jan 27.
de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Study Documents
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Related Links
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study homepage
Other Identifiers
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SENOMAC
Identifier Type: -
Identifier Source: org_study_id
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