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Could less surgery be just as effective for breast cancer patients?

NCT ID NCT03513614

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase III trial tests whether a less extensive lymph node surgery (tailored axillary surgery) followed by radiotherapy works as well as the standard full lymph node removal in women with breast cancer that has spread to the lymph nodes. The study involves 1,500 participants and aims to see if the gentler approach can reduce side effects like arm swelling without increasing the risk of cancer coming back. Results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tailored axillary surgery and radiotherapy
What this could lead to
If successful, this approach could spare many women with breast cancer from the side effects of full lymph node removal, such as arm swelling and pain, while keeping the same cancer control.
What could go wrong
This is a large phase III trial, but results are not yet available. There is a risk that the less extensive surgery may not control the cancer as well as the standard approach, leading to higher recurrence rates.

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 1,500 people

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

Started

Aug 2018

Expected to finish

Dec 2036

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: Inclusion criteria at pre-registration: * Written informed consent according to ICH/GCP regulations prior to any trial specific procedures. * Breast cancer, node positive detected by palpation or imaging (with or without planned neoadjuvant treatment) * Female or male aged ≥ 18 years * Ability to complete the Quality of Life questionnaires Inclusion criteria at registration: * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC \[42\] stage II-III (all molecular subtypes allowed): * Node-positivity detected by imaging (iN+) and confirmed by pathology * Node-positivity detected by palpation (cN1-3) and confirmed by pathology * Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present * Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section 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 * Most suspicious axillary lymph node clipped * Baseline Quality of Life questionnaire has been completed * WHO performance status 0-2 * Adequate condition for general anesthesia and breast cancer surgery * Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and thereafter during the time recommended by the guidelines for adjuvant systemic therapies. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential. * Men agree not to father a child during trial treatment and thereafter during 6 months. Inclusion criteria at randomization (intraoperatively) * Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed): * Node-positivity initially detected by imaging and non-palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in SLN or non SLN in case of prior neoadjuvant treatment * Node-positivity initially palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in case of prior neoadjuvant treatment * Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers to the stage before neoadjuvant treatment) \*\*Note: If the fine needle aspiration or core biopsy of the clipped node after neoadjuvant treatment unequivocally shows cancer, repeated confirmation of residual disease by intraoperative frozen section is not mandatory Exclusion Criteria: Exclusion criteria at pre-registration: Any potential patient who meets any of the following criteria has to be excluded from entering the trial. * Stage IV breast cancer * Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed) * Clinical N2b breast cancer (clinical N2a is allowed) * Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the trial treatment * Prior axillary surgery (except prior sentinel node procedure in case of in- breast recurrence) * Prior regional radiotherapy * 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. * Treatment with any experimental drug within 30 days of pre-registration * 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): Any potential patient who meets any of the following criteria has to be excluded from the trial. * Absence of clip in the specimen radiography * Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS) * No SLN identified in the axilla

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Node positive breast cancer

Contacts and locations

Locations

  • Alexandra General Hospital

    Athens, 115 28, Greece

  • Athens Medical Center Iatriko

    Marousi, 151 25, Greece

  • Attikon University Hospital

    Chaïdári, Athens, 124 62, Greece

  • Bacs-Kiskun Country Hospital

    Kecskemét, 6000, Hungary

  • Bethesda Spital Basel, Gynäkologie und Geburtshilfe

    Basel, 4052, Switzerland

  • Breast Centre of Clinical Hospital

    Rijeka, 51000, Croatia

  • Breast center Fribourg

    Fribourg, 1700, Switzerland

  • Brust-Zentrum Zürich (Seefeld)

    Zurich, 8008, Switzerland

  • Brustzentrum Basel und Netzwerk

    Allschwil, 4123, Switzerland

  • Brustzentrum Bern, Lindenhofgruppe Centerclinic

    Bern, 3011, Switzerland

  • Brustzentrum Thurgau

    Frauenfeld, 8501, Switzerland

  • CIUSSS du Centre Ouest-de-l'Île-de-Montréal, Jewish General Hospital

    Montreal, 3755, Canada

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, 1011, Switzerland

  • Centro di Senologia della Svizzera Italiana CSSI

    Lugano, 6970, Switzerland

  • Clinique de Genolier

    Genolier, 1272, Switzerland

  • Clinique de Grangettes

    Chêne-Bougeries, 1224, Switzerland

  • Duke University/Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Fondazione Policlinico Universitario "Agostino Gemelli" di Roma

    Rome, 00168, Italy

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • HRUHC Sestre milosdrnice

    Zagreb, Croatia

  • HUG - Hôpitaux Universitaires de Genève

    Geneva, 1205, Switzerland

  • Hanusch Hospital Vienna

    Vienna, 1140, Austria

  • Helios University Hospital Wuppertal

    Wuppertal, 42283, Germany

  • Hirslanden Klinik St. Anna

    Lucerne, 6006, Switzerland

  • Hôpital Neuchâtelois

    La Chaux-de-Fonds, 2300, Switzerland

  • Hôpital du Valais / Hôpital de Sion

    Sion, 1950, Switzerland

  • Iaso Maternity Hospital

    Marousi, 151 23, Greece

  • Institute of Oncology "Angel H. Roffo

    Buenos Aires, C1417, Argentina

  • KEM | Evang. Kliniken Essen-Mitte gGmbH

    Essen, 45136, Germany

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Baden

    Baden, 5404, Switzerland

  • Kantonsspital Graubünden

    Chur, 7000, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000, Switzerland

  • Kantonsspital Winterthur, Brustzentrum

    Winterthur, 8401, Switzerland

  • Klinikum Wels-Grieskrichen GmbH

    Wels, 4600, Austria

  • Krankenhaus Dornbirn

    Dornbirn, 6850, Austria

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800, Austria

  • Larissa General University Hospital

    Larissa, 413 34, Greece

  • Luzerner Kantonsspital - Brustzentrum

    Lucerne, 6000, Switzerland

  • Medical University of Innsbruck, Department of Gynecology

    Innsbruck, 6020, Austria

  • Medizinische Universität Wien - Klinik für Chirurgie

    Vienna, 1090, Austria

  • Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde

    Vienna, 1090, Austria

  • National Cancer Institut

    Vilnius, 08406, Lithuania

  • National Institute of Oncology

    Budapest, 1122, Hungary

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

    Georgsmarienhütte, 49124, Germany

  • Ordens Kinikum Linz, Barmherzige Schwestern

    Linz, 4010, Austria

  • Ospedale MultiMedica Castellanza

    Castellanza, 21053, Italy

  • Pauls Stradinš Clinical University Hospital

    Riga, 1002, Latvia

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sanatorio Parque Breast Cancer Center

    Rosario, Santa Fe Province, S2000, Argentina

  • Spital Limmattal

    Schlieren, 8952, Switzerland

  • Spital Zollikerberg

    Zollikerberg, 8125, Switzerland

  • Stadtspital Triemli

    Zurich, 8063, Switzerland

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

  • Tumor-and Breast centre Ostschweiz

    Sankt Gallen, 9016, Switzerland

  • University Hospital of Heraklion

    Heraklion, Crete, 71500, Greece

  • University Hospital of Patras

    Pátrai, 265 04, Greece

  • University of Szeged

    Szeged, 6720, Hungary

  • Universitäts Spital Zürich

    Zurich, 8091, Switzerland

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU

    Salzburg, 5020, Austria

  • Universitätsklinikum Heidelberg, Sektion Senologie

    Heidelberg, 69120, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus

    Karlsruhe, 76199, Germany

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814, United States

More trials for these conditions

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