What this study is
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.
What's being tested
- Axillary lymph node dissection (ALND)
Intervention · PROCEDURE
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)
Intervention · PROCEDURE
Axillary irradiation
Study details
- Official title
- Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery: An International, Randomized Superiority Trial (OPBC-10/ NOAX)
- Sponsor
- University Hospital, Basel, Switzerland
- Conditions
- Breast Cancer
- Enrolling
- 1,060 people
- Starts
- 2026-01-01
- Est. completion
- 2037-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
- Absence of clip in the specimen radiography.
- Palpable disease left behind in the axilla after TAS.
- No SLN identified in the axilla.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (55)
55 openWalter Reed National Military Medical Center
Bethesda, Maryland, United States
- Annesley Copeland · Contactannesley.w.copeland.civ@health.mil
Not yet recruitingDuke University/Duke Cancer Center
Durham, North Carolina, United States
- Maggie DiNome · Contactmaggie.dinome@duke.edu
Not yet recruitingFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
- Austin Williams · Contactaustin.williams@fccc.edu
Recruiting
52 sites outside the US
- Recruiting
- Recruiting
MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
Innsbruck, Austria
- Daniel Egle · Contactdaniel.egle@tirol-kliniken.at
Recruiting- Recruiting
Medical University Vienna, Department of Gynecology
Vienna, Austria
- Christian Singer · Contactchristian.singer@meduniwien.ac.at
Not yet recruitingMedical University Vienna, Department of Surgery
Vienna, Austria
- Ruth Exner · Contactruth.exner@meduniwien.ac.at
RecruitingCIUSSS du Centre Ouest-de-l 'Ile-de-Montréal
Montreal, Canada
- Stephanie Wong · Contactsm.wong@mcgill.ca
RecruitingBreast Centre of Clinical Hospital, Rijeka
Rijeka, Croatia
- Ana Car Peterko Car Peterko · Contactanacarpeterko@gmail.com
Not yet recruitingUniversity Hospital Heidelberg, Women's Clinic
Heidelberg, Germany
- Jörg Heil · Contactjoerg.heil@med.uni-heidelberg.de
RecruitingBrustzentrum Heidelberg Klinik St. Elisabeth GmbH
Heidelberg, Germany
- Jörg Heil · Contactjoerg.heil@kse-hd.de
RecruitingBreast Center Osnabrück
Osnabrück, Germany
- Thorsten Heilmann · Contact
RecruitingHELIOS Universitätsklinikum Wuppertal
Wuppertal, Germany
- Vesna Bjelic-Radisic · ContactVesna.Bjelic-Radisic@helios-gesundheit.de
Not yet recruiting- Not yet recruiting
- Not yet recruiting
- Not yet recruiting
Cork University Hospital
Cork, Ireland
- Mark Corrigan · Contact
Not yet recruiting- Not yet recruiting
- Not yet recruiting
- Not yet recruiting
- Recruiting
- Not yet recruiting
Policlinico Universitario "Agostino Gemelli
Rome, Italy
- Gianluca Franceschini · Contactgianlucafranceschini70@gmail.com
Not yet recruitingPauls Stradiņš Clinical University Hospital
Riga, Latvia
- Jelena Maksimenko · ContactJelena.Maksimenko@stradini.lv
Recruiting- Recruiting
- Recruiting
Breast Surgery Service, University Hospital Basel
Basel, Switzerland
- Walter P. Weber, Prof. Dr. med. · Contact+41 61 328 61 49walter.weber@usb.ch
- Walter P. Weber, Prof. Dr. med. · Principal investigator
Recruiting- Not yet recruiting
- Not yet recruiting
Clinique des Grangettes
Chêne-Bougeries, Switzerland
- Conny Vrieling · Contactconny.vrieling@grangettes.ch
Recruiting- Recruiting
- Recruiting
- Recruiting
- Recruiting
- Recruiting
- Recruiting
Centro di Senologia della Svizzera Italiana
Lugano, Switzerland
- Maria Luisa Gasparri · ContactMariaLuisa.Gasparri@eoc.ch
Recruiting- Recruiting
- Recruiting
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
- Joanna Paciorkowska · ContactJoanna.Paciorkowska@h-och.ch
RecruitingTumor-& Brustzentrum Ostschweiz St. Gallen
Sankt Gallen, Switzerland
- Michael Knauer · Contactmichael.knauer@tbz-ost.ch
RecruitingSchaffhausen Cantonal Hospital
Schaffhausen, Switzerland
- Deborah Admaty · ContactDeborah.Admaty@spitaeler-sh.ch
Recruiting- Recruiting
Hôpital du Valais, Hôpital de Sion
Sion, Switzerland
- Colin Simonson · Contactcolin.simonson@hopitalvs.ch
Recruiting- Not yet recruiting
- Recruiting
Spital Zollikerberg
Zollikerberg, Switzerland
- Hisham Fansa · Contacthisham.fansa@spitalzollikerberg.ch
Recruiting- Recruiting
Stadtspital Triemli
Zurich, Switzerland
- Heike Ruth Passmann Kegel · ContactHeike.Passmann@stadtspital.ch
RecruitingUniversity Hospital Zürich
Zurich, Switzerland
- Heike Frauchiger-Heuer · ContactHeike.Frauchiger-Heuer@usz.ch
RecruitingDepartment of General Surgery, Breast Unit, Istanbul Faculty of Medicine, Istanbul University
Istanbul, Turkey (Türkiye)
- Neslihan Cabioglu · Contactneslicab@yahoo.com
Not yet recruitingIstanbul Bağcılar Training and Research Hospital
Istanbul, Turkey (Türkiye)
- Merve Tokoçin · Contactmervetokocin@gmail.com
Not yet recruiting
Study team
Sponsor
University Hospital, Basel, Switzerland
Study ID 2025-01460; NOAX; bb24Weber2
Principal investigator
Walter P. Weber, Prof. Dr. med.
Breast Surgery Service, University Hospital Basel
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.