Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Change in arm-related Quality of Life (QoL) — From baseline to 2 years after randomization
The arm subscale (ARM) of the FACT-B+4 is used to assess arm-related QoL.The FACT-B comprises five subscales: physical well-being (seven items), social well-being (seven items), emotional well-being (six items), functional well-being (seven items), and concerns specific to patients with breast cancer (13 items). The FACT-B+4 questionnaire consists of the FACT-B subscales and the additional ARM subscale including five questions related to arm morbidity with four additional validated arm morbidity items that are added to the one item on arm morbidity already included in the FACT-B questionnaire. Patients are asked to indicate on a five- point scale from 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), to 4 (very much), to what degree each statement applied over the previous 7 days. The individual scoring of each question is inverted and added up to the total score ranging between 0 and 20 points, higher scores representing less arm problems. - Occurrence of lymphedema — From baseline to 2 years after randomization
Bilateral measurements will be obtained 10 cm above and 5 cm below the olecranon process on both the ipsilateral and contralateral upper extremities. The change in ipsilateral upper- extremity circumference, corrected for any change in the contralateral upper extremity, will be calculated using the following formula: L = (Ia - Ib) - (Ca- Cb). It indicates ipsilateral upper-extremity circumference, C indicates contralateral upper- extremity circumference, a indicates assessments during trial treatment and follow-up, and b indicates baseline assessment. L will be calculated for both upper arm and forearm, and lymphedema is defined as present if L \> 2 cm for either location. The proportion of patients with lymphedema will be calculated.
Trial sites (54)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More University Hospital, Basel, Switzerland trials in Canada
Other trials for the same condition
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 Canada