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NCT07140172NARecruiting

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery

University Hospital, Basel, Switzerland

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

Inclusion Criteria at screening: * Written informed consent according to ICH/GCP regulations prior to any trial specific procedures. * Patients ≥ 18 years of age. * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/ International Union Against Cancer (AJCC/UICC) stage II-III (all molecular subtypes allowed). * Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology. * Node-positivity palpable (cN1-3) and confirmed by pathology. * Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present. * Eligible for primary ALND or SLN procedure and either: * Newly diagnosed. * Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT. * Upfront surgery setting. * Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.) * Ability to complete the QoL questionnaires. * WHO performance status 0-2 * Adequate condition for general anesthesia, breast cancer surgery and radiotherapy. * Adult patients (≥18 years of age). * Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and thereafter during the time recommended by the guidelines - also for adjuvant systemic therapies. A negative pregnancy test before registration is required for all women of child-bearing potential. * Men agree not to father a child during trial treatment and for 6 months afterward. Exclusion criteria at screening: * Stage IV breast cancer. * Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed). * Clinical N2b breast cancer (clinical N2a is allowed). * Contralateral breast cancer within 3 years. * Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence). * Prior regional radiotherapy. * Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months. * History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer. * Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. Exclusion criteria at randomization (intraoperatively): * Absence of clip in the specimen radiography. * Palpable disease left behind in the axilla after TAS. * No SLN identified in the axilla.

Interventions

PROCEDURE

Axillary lymph node dissection (ALND)

PROCEDURE

Axillary radiotherapy (ART)

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Conditions

Breast Cancer

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)