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Breast CancerOPBC-10/ NOAXNCT07140172

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

A study testing Axillary lymph node dissection (ALND) and Axillary radiotherapy (ART) in people with Breast Cancer, run by University Hospital, Basel, Switzerland at 55 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Axillary lymph node dissection (ALND) and Axillary radiotherapy (ART)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,060 participants
Where
55 sitesin 11 countries
Study dates
1 Jan 2026to Dec 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

55 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Walter P. Weber, Prof. Dr. med. contact

+41 61 328 61 49

walter.weber@usb.ch

OPBC project management team contact

+41 61 55 65134

noax.trial@usb.ch

55 sites in 11 countries

Switzerland27 sites, 27 recruiting

  • Cantonal Hospital Aarau

    Aarau

    Maximilian Klar, maximilian.klar@ksa.ch

    Recruiting

  • Kantonsspital Baden

    Baden

    Cornelia Leo, cornelia.leo@ksb.ch

    Recruiting

  • Breast Surgery Service, University Hospital Basel

    Basel, 4031

    Walter P. Weber, Prof. Dr. med., +41 61 328 61 49, walter.weber@usb.ch

    Walter P. Weber, Prof. Dr. med.

    Recruiting

  • University Hospital of Bern (Inselspital)

    Bern

    Petia Kiene, petia.kiene@insel.ch

    Not yet recruiting

  • Spital Bülach

    Bülach

    Seda Schmädecker, seda.schmaedecker@spitalbuelach.ch

    Not yet recruiting

  • Clinique des Grangettes

    Chêne-Bougeries, 1224

    Conny Vrieling, conny.vrieling@grangettes.ch

    Recruiting

  • Graubünden Cantonal Hospital

    Chur

    Martina Maranta, martina.maranta@ksgr.ch

    Recruiting

  • Spital Thurgau

    Frauenfeld, 8500

    Stephanie Hofmann, stephanie.hofmann@stgag.ch

    Recruiting

  • Hôpitaux Universitaires de Genève

    Geneva

    Giang Thanh Lam, giang.t.lam@hcuge.ch

    Recruiting

  • Clinique de Genolier

    Genolier

    Magdalena Kohlik, mkohlik@genolier.net

    Recruiting

  • Hirslandenklinik St. Anna

    Lucerne

    Peter Dubsky, peter.dubsky@hirslanden.ch

    Recruiting

  • Kantonsspital Luzern

    Lucerne

    Kathrin Schwedler, kathrin.schwedler@luks.ch

    Recruiting

  • Centro di Senologia della Svizzera Italiana

    Lugano

    Maria Luisa Gasparri, MariaLuisa.Gasparri@eoc.ch

    Recruiting

  • Ticino Breast Center

    Lugano

    Damire De Monaco, damir.demonaco@affidea.ch

    Recruiting

  • Hôpital Neuchâtelois

    Neuchâtel

    Alexis Léger, alexis.leger@rhne.ch

    Recruiting

  • Bethesda Hospital Basel

    Pratteln

    Dieter Müller, dmueller@muellerhess.com

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen

    Joanna Paciorkowska, Joanna.Paciorkowska@h-och.ch

    Recruiting

  • Tumor-& Brustzentrum Ostschweiz St. Gallen

    Sankt Gallen

    Michael Knauer, michael.knauer@tbz-ost.ch

    Recruiting

  • Schaffhausen Cantonal Hospital

    Schaffhausen

    Deborah Admaty, Deborah.Admaty@spitaeler-sh.ch

    Recruiting

  • Spital Limmattal

    Schlieren

    Kathrin Kimmig, Kathrin.Kimmig@spital-limmattal.ch

    Recruiting

  • Hôpital du Valais, Hôpital de Sion

    Sion

    Colin Simonson, colin.simonson@hopitalvs.ch

    Recruiting

  • Bürgerspital Solothurn

    Solothurn

    Laura Knabben, laura.knabben@spital.so.ch

    Not yet recruiting

  • Kantonsspital Winterthur

    Winterthur

    Denise Vorburger, denise.vorburger@ksw.ch

    Recruiting

  • Spital Zollikerberg

    Zollikerberg

    Hisham Fansa, hisham.fansa@spitalzollikerberg.ch

    Recruiting

  • Brustzentrum Zürich (Seefeld)

    Zurich, 8008

    Kavitha Däster, kavitha.daester@affidea.ch

    Recruiting

  • Stadtspital Triemli

    Zurich

    Heike Ruth Passmann Kegel, Heike.Passmann@stadtspital.ch

    Recruiting

  • University Hospital Zürich

    Zurich

    Heike Frauchiger-Heuer, Heike.Frauchiger-Heuer@usz.ch

    Recruiting

Other trials in Switzerland

Austria6 sites, 6 recruiting

  • KH Dornbirn

    Dornbirn

    Christopher Hager, christopher.hager@dornbirn.at

    Recruiting

  • LKH Feldkirch

    Feldkirch

    Angelika Wolfrum, angelika.wolfrum@lkhf.at

    Recruiting

  • MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

    Innsbruck

    Daniel Egle, daniel.egle@tirol-kliniken.at

    Recruiting

  • Ordensklinikum Linz

    Linz

    Markus Acko, markus.acko@ordensklinikum.at

    Recruiting

  • Medical University Vienna, Department of Gynecology

    Vienna

    Christian Singer, christian.singer@meduniwien.ac.at

    Not yet recruiting

  • Medical University Vienna, Department of Surgery

    Vienna

    Ruth Exner, ruth.exner@meduniwien.ac.at

    Recruiting

Other trials in Austria

Ireland5 sites, 5 recruiting

  • Cork University Hospital

    Cork

    Mark Corrigan

    Not yet recruiting

  • St- Luke's Hospital Dublin

    Dublin

    Frances Duane, fran.duane@slh.ie

    Not yet recruiting

  • St. James's Hospital Dublin

    Dublin

    Elizabeth Connolly, emconnolly@stjames.ie

    Not yet recruiting

  • St. Vincent's University Hospital

    Dublin

    Michael Boland, michaelboland@rcsi.ie

    Not yet recruiting

  • University Hospital Galway

    Galway

    Aoife Lowery, alowery@universityofgalway.ie

    Recruiting

Other trials in Ireland

Germany4 sites, 4 recruiting

  • University Hospital Heidelberg, Women's Clinic

    Heidelberg, 69120

    Jörg Heil, joerg.heil@med.uni-heidelberg.de

    Recruiting

  • Brustzentrum Heidelberg Klinik St. Elisabeth GmbH

    Heidelberg

    Jörg Heil, joerg.heil@kse-hd.de

    Recruiting

  • Breast Center Osnabrück

    Osnabrück

    Thorsten Heilmann

    Recruiting

  • HELIOS Universitätsklinikum Wuppertal

    Wuppertal

    Vesna Bjelic-Radisic, Vesna.Bjelic-Radisic@helios-gesundheit.de

    Not yet recruiting

Other trials in Germany

United States3 sites, 3 recruiting

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814

    Annesley Copeland, annesley.w.copeland.civ@health.mil

    Not yet recruiting

  • Duke University/Duke Cancer Center

    Durham, North Carolina, 27710

    Maggie DiNome, maggie.dinome@duke.edu

    Not yet recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Austin Williams, austin.williams@fccc.edu

    Recruiting

Other trials in United States

Greece3 sites, 3 recruiting

  • "Alexandra" Hospital, Athens

    Athens

    George Pissakas, pissakasg@gmail.com

    Not yet recruiting

  • University Hospital of Heraklion

    Heraklion

    Eelco de Bree, debree@med.uoc.gr

    Not yet recruiting

  • University Hospital of Larissa

    Larissa

    Antigoni Poultsidi, apoultsidi@uth.gr

    Not yet recruiting

Other trials in Greece

Italy2 sites, 2 recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova

    Massimo Ferrucci, massimoferrucci@gmail.com

    Not yet recruiting

  • Policlinico Universitario "Agostino Gemelli

    Rome

    Gianluca Franceschini, gianlucafranceschini70@gmail.com

    Not yet recruiting

Other trials in Italy

Turkey (Türkiye)2 sites, 2 recruiting

  • Department of General Surgery, Breast Unit, Istanbul Faculty of Medicine, Istanbul University

    Istanbul

    Neslihan Cabioglu, neslicab@yahoo.com

    Not yet recruiting

  • Istanbul Bağcılar Training and Research Hospital

    Istanbul

    Merve Tokoçin, mervetokocin@gmail.com

    Not yet recruiting

Other trials in Turkey (Türkiye)

Canada1 site, 1 recruiting

  • CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal

    Montreal

    Stephanie Wong, sm.wong@mcgill.ca

    Recruiting

Other trials in Canada

Croatia1 site, 1 recruiting

  • Breast Centre of Clinical Hospital, Rijeka

    Rijeka

    Ana Car Peterko Car Peterko, anacarpeterko@gmail.com

    Not yet recruiting

Other trials in Croatia

Latvia1 site, 1 recruiting

  • Pauls Stradiņš Clinical University Hospital

    Riga

    Jelena Maksimenko, Jelena.Maksimenko@stradini.lv

    Recruiting

Other trials in Latvia

About this study

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)

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Axillary lymph node dissection (ALND), Axillary radiotherapy (ART)
Keywords
axillary lymph node dissection (ALND), axillary radiotherapy (ART), tailored axillary surgery (TAS), clinically node positive breast cancer (cN+ BC), sentinel lymph node biopsy (SLNB), Breast cancer-specific survival (BCSS), NOAX, OPBC-10, Lymphedema, Quality of life (QoL)
Medical subject headings
Breast Neoplasms, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary lymph node dissection (ALND)Procedure or surgery

    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)Procedure or surgery

    Axillary irradiation

Study groups in NCT07140172
Study groupRoleWhat they receive
Arm A (Control): ALNDActive comparator1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. Surgery: ALND - current standard of care, with the intention to remove the entire soft tissue within the anatomical borders of the axilla. 3. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).
Receives: Procedure: Axillary lymph node dissection (ALND)
Arm B (Investigational): ARTActive comparator1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes. 2. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).TAS + breast/chest wall and axillary irradiation (ART) 3. Radiotherapy: Axillary radiotherapy (ART).
Receives: Procedure: Axillary radiotherapy (ART)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in arm-related Quality of Life (QoL)

    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.

    Measured: From baseline to 2 years after randomization

  2. Occurrence of lymphedema

    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.

    Measured: From baseline to 2 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2025
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completionDec 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
International, multicenter, randomized controlled, superiority trial comparing TAS and ART (experimental group) to ALND (control group) in terms of arm-related QoL and occurrence of lymphedema two years after randomization (co-primary endpoints).
Masking
None (open label)
Enrolment
1,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07140172
Sponsor's protocol ID
2025-01460; NOAX; bb24Weber2
Other IDs
2025
Acronym
OPBC-10/ NOAX
Status last verified
Oct 2026
First submitted
18 Aug 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Axillary lymph node dissection (ALND) and Axillary radiotherapy (ART) in people with Breast Cancer, run by University Hospital, Basel, Switzerland at 55 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Switzerland, Austria, Ireland, Germany, United States and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Walter P. Weber, Prof. Dr. med. (+41 61 328 61 49, walter.weber@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in arm-related Quality of Life (QoL) (time frame: From baseline to 2 years after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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OPBC-10/ NOAX Clinical Trial NCT07140172 | AzTrials