Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Start Date
1/1/2026
Completion Date
12/1/2037
Summary
This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
Detailed Description
Despite major morbidity, axillary lymph node dissection (ALND) is standard of care in patients with clinically node positive breast cancer (cN+ BC) who undergo upfront surgery, which is frequently indicated in case of luminal biology. Tailored axillary surgery (TAS) was shown to selectively target positive nodes, thereby removing significantly more nodes than sentinel lymph node biopsy (SLNB), but less nodes than ALND. Therefore, it is currently unclear if TAS in combination with axillary radiotherapy (ART) exposes the axilla to less harm compared to ALND. It is hypothesized that patient's quality of life (QoL) and morbidity can be improved by replacing ALND with the combination of TAS and ART in patients undergoing upfront surgery. The main goal of this trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related QoL and occurrence of lymphedema two years after randomization.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Axillary lymph node dissection (ALND)
Axillary radiotherapy (ART)
Conditions
Locations
Walter Reed National Military Medical Center
Bethesda, Maryland 20814
United States
Duke University/Duke Cancer Center
Durham, North Carolina 27710
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
KH Dornbirn
Dornbirn,
Austria
LKH Feldkirch
Feldkirch,
Austria
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck,
Austria
Ordensklinikum Linz
Linz,
Austria
Medical University Vienna, Department of Gynecology
Vienna,
Austria
Medical University Vienna, Department of Surgery
Vienna,
Austria
CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal
Montreal,
Canada
Breast Centre of Clinical Hospital, Rijeka
Rijeka,
Croatia
University Hospital Heidelberg, Women's Clinic
Heidelberg, 69120
Germany
Brustzentrum Heidelberg Klinik St. Elisabeth GmbH
Heidelberg,
Germany
Breast Center Osnabrück
Osnabrück,
Germany
HELIOS Universitätsklinikum Wuppertal
Wuppertal,
Germany
"Alexandra" Hospital, Athens
Athens,
Greece
University Hospital of Heraklion
Heraklion,
Greece
University Hospital of Larissa
Larissa,
Greece
Cork University Hospital
Cork,
Ireland
Beaumont Hospital Dublin
Dublin,
Ireland
St- Luke's Hospital Dublin
Dublin,
Ireland
St. James's Hospital Dublin
Dublin,
Ireland
St. Vincent's University Hospital
Dublin,
Ireland
University Hospital Galway
Galway,
Ireland
Istituto Oncologico Veneto IRCCS
Padova,
Italy
Policlinico Universitario "Agostino Gemelli
Rome,
Italy
Pauls Stradiņš Clinical University Hospital
Riga,
Latvia
Kantonsspital Baden
Baden,
Switzerland
Breast Surgery Service, University Hospital Basel
Basel, 4031
Switzerland
University Hospital of Bern (Inselspital)
Bern,
Switzerland
Clinique des Grangettes
Chêne-Bougeries, 1224
Switzerland
Graubünden Cantonal Hospital
Chur,
Switzerland
Spital Thurgau
Frauenfeld, 8500
Switzerland
Hôpitaux Universitaires de Genève
Geneva,
Switzerland
Clinique de Genolier
Genolier,
Switzerland
Hirslandenklinik St. Anna
Lucerne,
Switzerland
Kantonsspital Luzern
Lucerne,
Switzerland
Centro di Senologia della Svizzera Italiana
Lugano,
Switzerland
Ticino Breast Center
Lugano,
Switzerland
Hôpital Neuchâtelois
Neuchâtel,
Switzerland
Bethesda Hospital Basel
Pratteln,
Switzerland
Kantonsspital St. Gallen
Sankt Gallen,
Switzerland
Tumor-& Brustzentrum Ostschweiz St. Gallen
Sankt Gallen,
Switzerland
Schaffhausen Cantonal Hospital
Schaffhausen,
Switzerland
Spital Limmattal
Schlieren,
Switzerland
Hôpital du Valais, Hôpital de Sion
Sion,
Switzerland
Kantonsspital Winterthur
Winterthur,
Switzerland
Spital Zollikerberg
Zollikerberg,
Switzerland
Brustzentrum Zürich (Seefeld)
Zurich, 8008
Switzerland
Stadtspital Triemli
Zurich,
Switzerland
University Hospital Zürich
Zurich,
Switzerland
İstanbul Bağcılar Training and Research Hospital
Istanbul,
Turkey (Türkiye)
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul,
Turkey (Türkiye)