Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2024-05-15
2025-06-30
Brief Summary
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Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
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Detailed Description
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For patients undergoing NAC, standard of care includes checking the lymph nodes under the arm (axillary lymph nodes) using a procedure called Sentinel lymph node biopsy to determine if the cancer has spread. In cases where the cancer has spread to the lymph nodes but then shrinks or disappears after chemotherapy, special techniques like dual tracer mapping, targeted axillary dissection, or the Marking Axillary Lymph Nodes with Iodine Seeds procedure are used to ensure accurate biopsy results.
For patients whose cancer shrinks completely in the lymph nodes, it is generally safe to skip further surgery to remove more lymph nodes, a procedure called axillary lymph node dissection (ALND). However, if cancer remains in the lymph nodes, more lymph nodes are typically removed because there is a high chance that cancer is still present.
An increasing number of surgeons are starting to omit ALND, especially when only tiny amounts of cancer (micrometastases) remain. To ensure this practice is safe, real-world data on patient outcomes over time is needed.
This multicenter retrospective cohort study aims to assess the safety of omitting ALND in patients with residual micrometastases after NAC for breast cancer. The study analyzes data of breast cancer patients treated between 2013 and 2024 at more than 50 centers that are part of the Oncoplastic Breast Consortium.
The results of this study will provide valuable information to help doctors determine the best treatment approach for their patients.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* For Clinically Node negative (cN0) at presentation: any axillary staging technique including palpation is allowed. Dual tracer mapping is not required for Sentinel Lymph Node Biopsy (SLNB)
* For Clinically Node positive (cN+) at presentation: Biopsy proven confirmation is required. Staging techniques include: SLNB with dual mapping or targeted axillary dissection (Targeted Axillary Dissection, TAD: imaging-guided localization of sampled node in combination with Sentinel Lymph Node procedure with or without dual mapping) or the Marking Axillary Lymph Nodes with Iodine Seeds (MARI) procedure
* Completed neoadjuvant chemotherapy
* Residual micrometastases detected on SLNB or TAD or MARI (on frozen section or final pathology)
* Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
* Received axillary treatment with completion axillary lymph node dissection (ALND), axillary Radiotherapy (ART), both or none
* At least 1-year follow-up (inclusion should end in May 2023)
* Had surgery at any time point until May 2023 at the latest
* Prior history of stage I-III (not stage IV) breast cancer is allowed
Exclusion Criteria
* Presence of ITCs alone or macrometastases on the sentinel nodes (or TAD nodes or MARI node)
* Stage IV disease at presentation
* Inflammatory breast cancer at presentation
* Neoadjuvant endocrine therapy
* Micrometastases detected by One-step nucleic acid amplification (OSNA)
18 Years
100 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Walter Paul Weber, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Pauls Stradiņš Clinical University Hospital
Riga, , Latvia
Valleywise Health Medical Center
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California
San Francisco, California, United States
Providence Saint John's Cancer Institute
Santa Monica, California, United States
University of Miami
Coral Gables, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
National Cancer Institute
Vilnius, , Lithuania
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Sanatorio Modelo Quilmes
Quilmes, , Argentina
Chris O'Brien Lifehouse (COBL)
Sydney, , Australia
Ordensklinikum Linz GmbH
Linz, , Austria
Medical University of Vienna Chirurgie
Vienna, , Austria
Hospital de Base do Distrito Federal
Brasília, , Brazil
Sirio Libanes Hospital Brasilia
Brasília, , Brazil
Hospital Nossa Senhora das Graças
Curitiba, , Brazil
Hospital Geral de Fortaleza
Fortaleza, , Brazil
Instituto do Cancer do Ceará
Fortaleza, , Brazil
Instituto de Mastologia e Oncologia
Goiânia, , Brazil
Hospital de Câncer Araújo Jorge
Goiânia, , Brazil
Sirio Libanes Hospital
São Paulo, , Brazil
Instituto D'OR de Pesquisa e Ensino
São Paulo, , Brazil
Sir Mortimer B. Davis Jewish General Hospital
Montreal, , Canada
Arturo Lopez Perez Foundation
Providencia, , Chile
Institute of Radiation Medicine
Vitacura, , Chile
Clinical Hospital Center Rijeka
Rijeka, , Croatia
Mansoura oncology center
Al Mansurah, , Egypt
University Hospital Augsburg
Augsburg, , Germany
University Hospital Düsseldorf
Düsseldorf, , Germany
KEM | Clinics Essen-Mitte
Essen, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University Hospital Lübeck
Lübeck, , Germany
University General Hospital of Heraklion
Heraklion, , Greece
Athens Medical Center
Marousi, , Greece
Sheba Medical Center
Ramat Gan, , Israel
Insituto Europeo di Oncologia
Milan, , Italy
University Hospital Federico II
Napoli, , Italy
IOV Padua
Padua, , Italy
Clinici Scientifici Maugeri IRCCS
Pavia, , Italy
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Oslo University Hospital
Oslo, , Norway
Dow University of Health Sciences
Karachi, , Pakistan
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, , Peru
Instituto Nacional de Enfermedades Neoplasicas
Surquillo, , Peru
University Hospital Zielona Gora
Zielona Góra, , Poland
Champalimaud Foundation
Lisbon, , Portugal
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, , Russia
AGEL Mammacentrum sv. Agáty
Banská Bystrica, , Slovakia
Institute of Oncology Ljubljana
Ljubljana, , Slovenia
ASAN Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital del Mar d'Investigacions Mèdiques
Barcelona, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Hospital Universitario La Paz, ía Mamaria
Madrid, , Spain
Capio Saint Göran's Hospital
Stockholm, , Sweden
Cantonal Hospital Baden
Baden, , Switzerland
University Hospital Basel
Basel, , Switzerland
Campus SLB Sonnenhof AG
Bern, , Switzerland
Cantonal Hospital Luzern
Lucerne, , Switzerland
EOC Centro di Senologia della Svizzera Italiana
Lugano, , Switzerland
Tumor und Brustzentrum Ostschweiz
Sankt Gallen, , Switzerland
Cantonal Hospital Winterthur
Winterthur, , Switzerland
Zürich Breast Center
Zurich, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Gülhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Istanbul University Faculty of Medicine
Fatih, , Turkey (Türkiye)
Marmara University
Istanbul, , Turkey (Türkiye)
Zonguldak Bülent Ecevit University
Zonguldak, , Turkey (Türkiye)
Cambridge University Hospitals
Cambridge, , United Kingdom
Countries
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Other Identifiers
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2024-00186; bb24Weber
Identifier Type: -
Identifier Source: org_study_id
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