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Clinical Trials in Ireland / NCT07140172
Recruiting Not applicable

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

NCT07140172 · tracked via the Priya Life Science Ireland tracker
Sponsor
University Hospital, Basel, Switzerland
Phase
Not applicable
Started
2026-01-01
Last updated
2026-08-07

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Axillary lymph node dissection (ALND)Axillary radiotherapy (ART)

Axillary lymph node dissection (ALND): Surgical removal of lymphatic tissue within the anatomical boundaries of the axilla (standard of care in the upfront surgery setting in patients with cN+ BC)

Axillary radiotherapy (ART): Axillary irradiation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Walter Reed National Military Medical Center Bethesda Maryland Not Yet Recruiting
Duke University/Duke Cancer Center Durham North Carolina Not Yet Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
Swedish Cancer Institute Seattle Washington Not Yet Recruiting
KH Dornbirn Dornbirn Austria Recruiting
LKH Feldkirch Feldkirch Austria Recruiting
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck Innsbruck Austria Recruiting
Ordensklinikum Linz Linz Austria Recruiting
Medical University Vienna, Department of Gynecology Vienna Austria Not Yet Recruiting
Medical University Vienna, Department of Surgery Vienna Austria Recruiting
CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal Montreal Canada Recruiting
Breast Centre of Clinical Hospital, Rijeka Rijeka Croatia Not Yet Recruiting
University Hospital Heidelberg, Women's Clinic Heidelberg Germany Recruiting
Brustzentrum Heidelberg Klinik St. Elisabeth GmbH Heidelberg Germany Recruiting
Breast Center Osnabrück Osnabrück Germany Recruiting
HELIOS Universitätsklinikum Wuppertal Wuppertal Germany Not Yet Recruiting
"Alexandra" Hospital, Athens Athens Greece Not Yet Recruiting
University Hospital of Heraklion Heraklion Greece Not Yet Recruiting
University Hospital of Larissa Larissa Greece Not Yet Recruiting
Cork University Hospital Cork Ireland Not Yet Recruiting
Beaumont Hospital Dublin Dublin Ireland Not Yet Recruiting
St- Luke's Hospital Dublin Dublin Ireland Not Yet Recruiting
St. James's Hospital Dublin Dublin Ireland Not Yet Recruiting
St. Vincent's University Hospital Dublin Ireland Not Yet Recruiting
University Hospital Galway Galway Ireland Recruiting
Istituto Oncologico Veneto IRCCS Padova Italy Not Yet Recruiting
Policlinico Universitario "Agostino Gemelli Rome Italy Not Yet Recruiting
Pauls Stradiņš Clinical University Hospital Riga Latvia Recruiting
Kantonsspital Baden Baden Switzerland Recruiting
Breast Surgery Service, University Hospital Basel Basel Switzerland Recruiting
University Hospital of Bern (Inselspital) Bern Switzerland Not Yet Recruiting
Clinique des Grangettes Chêne-Bougeries Switzerland Recruiting
Graubünden Cantonal Hospital Chur Switzerland Recruiting
Spital Thurgau Frauenfeld Switzerland Recruiting
Hôpitaux Universitaires de Genève Geneva Switzerland Recruiting
Clinique de Genolier Genolier Switzerland Recruiting
Hirslandenklinik St. Anna Lucerne Switzerland Recruiting
Kantonsspital Luzern Lucerne Switzerland Recruiting
Centro di Senologia della Svizzera Italiana Lugano Switzerland Recruiting
Ticino Breast Center Lugano Switzerland Not Yet Recruiting

+ 14 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07140172 on ClinicalTrials.gov ↗ ← All trials in Ireland