Actively Recruiting
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Led by University Hospital, Basel, Switzerland · Updated on 2026-05-11
1060
Participants Needed
54
Research Sites
621 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Be 18 years of age or older
- Have node-positive breast cancer (stage II-III) confirmed by pathology in both primary tumor and lymph nodes
- Have node-positivity detected by imaging and confirmed by pathology, either non-palpable or palpable
- Have occult breast cancer with biopsy-proven axillary lymphatic metastasis
- Be eligible for primary ALND or sentinel lymph node procedure
- Be newly diagnosed or have isolated in-breast recurrence or a second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure, with at least 3 years disease free and no prior axillary dissection or radiotherapy
- Be planned for upfront surgery
- Have the most suspicious axillary lymph node clipped before surgery
- Be able to complete quality of life questionnaires
- Have a WHO performance status of 0 to 2
- Be in adequate condition for general anesthesia, breast cancer surgery, and radiotherapy
- Women of child-bearing potential must use effective contraception, not be pregnant or lactating, and agree not to become pregnant during and after treatment as recommended
- Men must agree not to father a child during treatment and for 6 months afterward
You will not qualify if you...
- Have stage IV breast cancer
- Have clinical N3c breast cancer without axillary disease
- Have clinical N2b breast cancer
- Have contralateral breast cancer within the past 3 years
- Have had prior axillary surgery except sentinel node biopsy in case of in-breast recurrence
- Have received prior regional radiotherapy
- Have received neoadjuvant treatment except bridging therapy less than 3 months
- Have a history of hematologic or primary solid tumor malignancy unless in remission for at least 3 years, except treated cervical carcinoma in situ or localized non-melanoma skin cancer
- Have any serious medical, psychiatric, psychological, familial, or geographical condition that may interfere with treatment or follow-up or increase risk of complications
- At randomization, absence of clip in specimen radiography
- Palpable disease left behind after tailored axillary surgery
- No sentinel lymph node identified in the axilla
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 54 locations
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
Not Yet Recruiting
2
Duke University/Duke Cancer Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Not Yet Recruiting
4
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Not Yet Recruiting
5
KH Dornbirn
Dornbirn, Austria
Not Yet Recruiting
6
LKH Feldkirch
Feldkirch, Austria
Not Yet Recruiting
7
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck, Austria
Actively Recruiting
8
Ordensklinikum Linz
Linz, Austria
Not Yet Recruiting
9
Medical University Vienna, Department of Gynecology
Vienna, Austria
Not Yet Recruiting
10
Medical University Vienna, Department of Surgery
Vienna, Austria
Not Yet Recruiting
11
CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal
Montreal, Canada
Not Yet Recruiting
12
Breast Centre of Clinical Hospital, Rijeka
Rijeka, Croatia
Not Yet Recruiting
13
University Hospital Heidelberg, Women's Clinic
Heidelberg, Germany, 69120
Actively Recruiting
14
Brustzentrum Heidelberg Klinik St. Elisabeth GmbH
Heidelberg, Germany
Actively Recruiting
15
Breast Center Osnabrück
Osnabrück, Germany
Not Yet Recruiting
16
HELIOS Universitätsklinikum Wuppertal
Wuppertal, Germany
Not Yet Recruiting
17
"Alexandra" Hospital, Athens
Athens, Greece
Not Yet Recruiting
18
University Hospital of Heraklion
Heraklion, Greece
Not Yet Recruiting
19
University Hospital of Larissa
Larissa, Greece
Not Yet Recruiting
20
Cork University Hospital
Cork, Ireland
Not Yet Recruiting
21
Beaumont Hospital Dublin
Dublin, Ireland
Not Yet Recruiting
22
St- Luke's Hospital Dublin
Dublin, Ireland
Not Yet Recruiting
23
St. James's Hospital Dublin
Dublin, Ireland
Not Yet Recruiting
24
St. Vincent's University Hospital
Dublin, Ireland
Not Yet Recruiting
25
University Hospital Galway
Galway, Ireland
Not Yet Recruiting
26
Istituto Oncologico Veneto IRCCS
Padova, Italy
Not Yet Recruiting
27
Policlinico Universitario "Agostino Gemelli
Rome, Italy
Not Yet Recruiting
28
Pauls Stradiņš Clinical University Hospital
Riga, Latvia
Not Yet Recruiting
29
Kantonsspital Baden
Baden, Switzerland
Actively Recruiting
30
Breast Surgery Service, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
31
University Hospital of Bern (Inselspital)
Bern, Switzerland
Not Yet Recruiting
32
Clinique des Grangettes
Chêne-Bougeries, Switzerland, 1224
Actively Recruiting
33
Graubünden Cantonal Hospital
Chur, Switzerland
Actively Recruiting
34
Spital Thurgau
Frauenfeld, Switzerland, 8500
Actively Recruiting
35
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Actively Recruiting
36
Clinique de Genolier
Genolier, Switzerland
Actively Recruiting
37
Hirslandenklinik St. Anna
Lucerne, Switzerland
Actively Recruiting
38
Kantonsspital Luzern
Lucerne, Switzerland
Actively Recruiting
39
Centro di Senologia della Svizzera Italiana
Lugano, Switzerland
Actively Recruiting
40
Ticino Breast Center
Lugano, Switzerland
Not Yet Recruiting
41
Hôpital Neuchâtelois
Neuchâtel, Switzerland
Actively Recruiting
42
Bethesda Hospital Basel
Pratteln, Switzerland
Not Yet Recruiting
43
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Not Yet Recruiting
44
Tumor-& Brustzentrum Ostschweiz St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
45
Schaffhausen Cantonal Hospital
Schaffhausen, Switzerland
Actively Recruiting
46
Spital Limmattal
Schlieren, Switzerland
Actively Recruiting
47
Hôpital du Valais, Hôpital de Sion
Sion, Switzerland
Actively Recruiting
48
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
49
Spital Zollikerberg
Zollikerberg, Switzerland
Actively Recruiting
50
Brustzentrum Zürich (Seefeld)
Zurich, Switzerland, 8008
Actively Recruiting
51
Stadtspital Triemli
Zurich, Switzerland
Actively Recruiting
52
University Hospital Zürich
Zurich, Switzerland
Not Yet Recruiting
53
İstanbul Bağcılar Training and Research Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
54
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
Research Team
W
Walter P. Weber, Prof. Dr. med.
CONTACT
O
OPBC project management team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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