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New trial aims to spare breast cancer patients from arm swelling

NCT ID NCT07140172

Symptom relief Sponsor: University Hospital, Basel, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study compares two ways to treat breast cancer that has spread to nearby lymph nodes: targeted radiotherapy or surgical removal of the nodes. The goal is to see which approach better preserves arm function and reduces the risk of long-term arm swelling. About 1,060 adults with node-positive breast cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,060 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Alexandra" Hospital, Athens

    NOT_YET_RECRUITING

    Athens, Greece

  • Beaumont Hospital Dublin

    NOT_YET_RECRUITING

    Dublin, Ireland

  • Bethesda Hospital Basel

    RECRUITING

    Pratteln, Switzerland

  • Breast Center Osnabrück

    RECRUITING

    Osnabrück, Germany

  • Breast Centre of Clinical Hospital, Rijeka

    NOT_YET_RECRUITING

    Rijeka, Croatia

  • Breast Surgery Service, University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • Brustzentrum Heidelberg Klinik St. Elisabeth GmbH

    RECRUITING

    Heidelberg, Germany

  • Brustzentrum Zürich (Seefeld)

    RECRUITING

    Zurich, 8008, Switzerland

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

    RECRUITING

    Montreal, Canada

  • Centro di Senologia della Svizzera Italiana

    RECRUITING

    Lugano, Switzerland

  • Clinique de Genolier

    RECRUITING

    Genolier, Switzerland

  • Clinique des Grangettes

    RECRUITING

    Chêne-Bougeries, 1224, Switzerland

  • Cork University Hospital

    NOT_YET_RECRUITING

    Cork, Ireland

  • Duke University/Duke Cancer Center

    NOT_YET_RECRUITING

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Graubünden Cantonal Hospital

    RECRUITING

    Chur, Switzerland

  • HELIOS Universitätsklinikum Wuppertal

    NOT_YET_RECRUITING

    Wuppertal, Germany

  • Hirslandenklinik St. Anna

    RECRUITING

    Lucerne, Switzerland

  • Hôpital Neuchâtelois

    RECRUITING

    Neuchâtel, Switzerland

  • Hôpital du Valais, Hôpital de Sion

    RECRUITING

    Sion, Switzerland

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, Switzerland

  • Istituto Oncologico Veneto IRCCS

    NOT_YET_RECRUITING

    Padova, Italy

  • KH Dornbirn

    RECRUITING

    Dornbirn, Austria

  • Kantonsspital Baden

    RECRUITING

    Baden, Switzerland

  • Kantonsspital Luzern

    RECRUITING

    Lucerne, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • Kantonsspital Winterthur

    RECRUITING

    Winterthur, Switzerland

  • LKH Feldkirch

    RECRUITING

    Feldkirch, Austria

  • MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Medical University Vienna, Department of Gynecology

    NOT_YET_RECRUITING

    Vienna, Austria

  • Medical University Vienna, Department of Surgery

    RECRUITING

    Vienna, Austria

  • Ordensklinikum Linz

    RECRUITING

    Linz, Austria

  • Pauls Stradiņš Clinical University Hospital

    RECRUITING

    Riga, Latvia

  • Policlinico Universitario "Agostino Gemelli

    NOT_YET_RECRUITING

    Rome, Italy

  • Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Schaffhausen Cantonal Hospital

    RECRUITING

    Schaffhausen, Switzerland

  • Spital Limmattal

    RECRUITING

    Schlieren, Switzerland

  • Spital Thurgau

    RECRUITING

    Frauenfeld, 8500, Switzerland

  • Spital Zollikerberg

    RECRUITING

    Zollikerberg, Switzerland

  • St- Luke's Hospital Dublin

    NOT_YET_RECRUITING

    Dublin, Ireland

  • St. James's Hospital Dublin

    NOT_YET_RECRUITING

    Dublin, Ireland

  • St. Vincent's University Hospital

    NOT_YET_RECRUITING

    Dublin, Ireland

  • Stadtspital Triemli

    RECRUITING

    Zurich, Switzerland

  • Swedish Cancer Institute

    NOT_YET_RECRUITING

    Seattle, Washington, 98104, United States

  • Ticino Breast Center

    NOT_YET_RECRUITING

    Lugano, Switzerland

  • Tumor-& Brustzentrum Ostschweiz St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • University Hospital Galway

    RECRUITING

    Galway, Ireland

  • University Hospital Heidelberg, Women's Clinic

    RECRUITING

    Heidelberg, 69120, Germany

  • University Hospital Zürich

    NOT_YET_RECRUITING

    Zurich, Switzerland

  • University Hospital of Bern (Inselspital)

    NOT_YET_RECRUITING

    Bern, Switzerland

  • University Hospital of Heraklion

    NOT_YET_RECRUITING

    Heraklion, Greece

  • University Hospital of Larissa

    NOT_YET_RECRUITING

    Larissa, Greece

  • Walter Reed National Military Medical Center

    NOT_YET_RECRUITING

    Bethesda, Maryland, 20814, United States

  • İstanbul Bağcılar Training and Research Hospital

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.