Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS) (TAXIS)

April 30, 2026 updated by: University Hospital, Basel, Switzerland

Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS). A Multicenter Randomized Phase III Trial (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101)

RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy.

PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The removal of all lymph nodes in the armpit through conventional axillary dissection has been standard care for all patients with breast cancer for almost a century. In the nineties, the sentinel lymph node procedure, which involves the selective removal of the first few affected lymph nodes, was introduced in clinical practice. Today, conventional axillary dissection is still performed on many women with breast cancer that has spread to the nodes. It is the cause for relevant morbidity in the form of lymphedema, impairment of shoulder mobility, sensation disorders and chronic pain in as much as one third of all women undergoing the procedure.

The TAXIS trial will evaluate the optimal treatment for breast cancer patients in terms of surgery and radiotherapy. In particular, it will investigate the value of tailored axillary surgery (TAS), a new technique that aims at selectively removing the positive lymph nodes. TAS combines the removal of palpably suspicious nodes with the sentinel procedure. TAS is a promising procedure that may significantly decrease morbidity in breast cancer patients by avoiding surgical overtreatment.

This trial has the potential to establish a new worldwide treatment standard with hopefully less side effects and a better quality of life, while keeping the same efficacy as provided by radical surgery.

The main objective of the trial is to show that TAS and axillary radiotherapy (RT) is non-inferior to ALND in terms of disease-free survival of node positive breast cancer patients at high risk of recurrence in the era of effective systemic therapy and extended regional nodal irradiation.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1417
        • Institute of Oncology "Angel H. Roffo
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Sanatorio Parque Breast Cancer Center
  • Austria
      • Dornbirn, Austria, 6850
        • Krankenhaus Dornbirn
      • Feldkirch, Austria, 6800
        • Landeskrankenhaus Feldkirch
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck, Department of Gynecology
      • Linz, Austria, 4010
        • Ordens Kinikum Linz, Barmherzige Schwestern
      • Salzburg, Austria, 5020
        • Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU
      • Vienna, Austria, 1140
        • Hanusch Hospital Vienna
      • Vienna, Austria, 1090
        • Medizinische Universität Wien - Klinik für Chirurgie
      • Vienna, Austria, 1090
        • Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskrichen GmbH
  • Canada
      • Montreal, Canada, 3755
        • CIUSSS du Centre Ouest-de-l'Île-de-Montréal, Jewish General Hospital
  • Croatia
      • Rijeka, Croatia, 51000
        • Breast Centre of Clinical Hospital
      • Zagreb, Croatia
        • HRUHC Sestre milosdrnice
  • Germany
      • Essen, Germany, 45136
        • KEM | Evang. Kliniken Essen-Mitte gGmbH
      • Georgsmarienhütte, Germany, 49124
        • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg, Sektion Senologie
      • Karlsruhe, Germany, 76199
        • ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus
      • Wuppertal, Germany, 42283
        • Helios University Hospital Wuppertal
  • Greece
      • Athens, Greece, 115 28
        • Alexandra General Hospital
      • Larissa, Greece, 413 34
        • Larissa General University Hospital
      • Marousi, Greece, 151 23
        • Iaso Maternity Hospital
      • Marousi, Greece, 151 25
        • Athens Medical Center Iatriko
      • Pátrai, Greece, 265 04
        • University Hospital of Patras
    • Athens
      • Chaïdári, Athens, Greece, 124 62
        • Attikon University Hospital
    • Crete
      • Heraklion, Crete, Greece, 71500
        • University Hospital of Heraklion
  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology
      • Kecskemét, Hungary, 6000
        • Bacs-Kiskun Country Hospital
      • Szeged, Hungary, 6720
        • University of Szeged
  • Italy
      • Castellanza, Italy, 21053
        • Ospedale MultiMedica Castellanza
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario "Agostino Gemelli" di Roma
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
  • Lithuania
      • Vilnius, Lithuania, 08406
        • National Cancer Institut
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
      • Allschwil, Switzerland, 4123
        • Brustzentrum Basel und Netzwerk
      • Baden, Switzerland, 5404
        • Kantonsspital Baden
      • Basel, Switzerland, 4031
        • Universitatsspital Basel
      • Basel, Switzerland, 4052
        • Bethesda Spital Basel, Gynäkologie und Geburtshilfe
      • Bern, Switzerland, 3011
        • Brustzentrum Bern, Lindenhofgruppe Centerclinic
      • Chur, Switzerland, 7000
        • Kantonsspital Graubunden
      • Chêne-Bougeries, Switzerland, 1224
        • Clinique de Grangettes
      • Frauenfeld, Switzerland, 8501
        • Brustzentrum Thurgau
      • Fribourg, Switzerland, 1700
        • Breast center Fribourg
      • Geneva, Switzerland, 1205
        • HUG - Hôpitaux Universitaires de Genève
      • Genolier, Switzerland, 1272
        • Clinique de Genolier
      • La Chaux-de-Fonds, Switzerland, 2300
        • Hôpital Neuchâtelois
      • Lausanne, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois CHUV
      • Lucerne, Switzerland, 6006
        • Hirslanden Klinik St. Anna
      • Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital - Brustzentrum
      • Lugano, Switzerland, 6970
        • Centro di Senologia della Svizzera Italiana CSSI
      • Sankt Gallen, Switzerland, 9000
        • Kantonsspital St. Gallen
      • Sankt Gallen, Switzerland, 9016
        • Tumor-and Breast centre Ostschweiz
      • Schlieren, Switzerland, 8952
        • Spital Limmattal
      • Sion, Switzerland, 1950
        • Hôpital du Valais / Hôpital de Sion
      • Winterthur, Switzerland, 8401
        • Kantonsspital Winterthur, Brustzentrum
      • Zollikerberg, Switzerland, 8125
        • Spital Zollikerberg
      • Zurich, Switzerland, 8063
        • Stadtspital Triemli
      • Zurich, Switzerland, 8008
        • Brust-Zentrum Zürich (Seefeld)
      • Zurich, Switzerland, 8091
        • Universitäts Spital Zürich
  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Walter Reed National Military Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University/Duke Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ALND
Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.
Procedure: Tailored axillary surgery - both Arms
Axillary lymph node dissection - Arm A
Radiation: Radiotherapy - Arm A
Regional nodal irradiation excluding the dissected axilla - Arm A
Active Comparator: No ALND
Tailored axillary surgery followed by regional nodal irradiation including the full axilla.
Procedure: Tailored axillary surgery - both Arms
Axillary lymph node dissection - Arm A
Radiation: Radiotherapy - Arm B
Regional nodal irradiation including the full axilla - Arm B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: at the occurrence of the event or latest 20 years after randomization of the last patient

The primary endpoint of this trial is DFS, defined as time from randomization until one of the following events, whichever comes first:

  • Local recurrence, regional recurrence, distant recurrence
  • Second breast cancer
  • Death from any cause Patients not experiencing an event will be censored at the date of the last available assessment.
at the occurrence of the event or latest 20 years after randomization of the last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: at the occurrence of the event or latest 20 years after randomization of the last patient
OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.
at the occurrence of the event or latest 20 years after randomization of the last patient
Breast cancer-specific survival (BCSS)
Time Frame: at the occurrence of the event or latest 20 years after randomization of the last patient
BCSS will be calculated from randomization until death from breast cancer. Patients not experiencing an event will be censored at the last date they were known to be alive.
at the occurrence of the event or latest 20 years after randomization of the last patient
Time to local recurrence (TTLR)
Time Frame: at the occurrence of the event or latest 20 years after randomization of the last patient
TTLR will be calculated from randomization until local recurrence or death from breast cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event will be censored at the date of the last available assessment.
at the occurrence of the event or latest 20 years after randomization of the last patient
Time to distant recurrence (TTDR)
Time Frame: at the occurrence of the event or latest 20 years after randomization of the last patient
TTDR will be calculated from randomization until distant recurrence or death from breast cancer. Patients not experiencing an event or patients who died due to other reasons before experiencing an event will be censored at the date of the last available assessment.
at the occurrence of the event or latest 20 years after randomization of the last patient
Physician reported morbidity outcomes (Lymphedema)
Time Frame: at baseline, at week 1 and 4 after surgery, before the beginning of radiotherapy. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 20 years after randomization of the last patient.
at baseline, at week 1 and 4 after surgery, before the beginning of radiotherapy. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 20 years after randomization of the last patient.
Physician reported morbidity outcomes (Decreased range of shoulder motion)
Time Frame: at baseline, at week 1 and 4 after surgery. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 10 years after randomization of the last patient.
at baseline, at week 1 and 4 after surgery. During follow-up: 9 and 12 months after randomization then every 6 months up to 3 years, then every year up to 10 years after randomization of the last patient.
Adverse events according to NCI CTCAE v4.03
Time Frame: from date of patient consent and up to 20 years after randomization of the last patient
Clipping-related AEs and specific AEs related to the surgical procedure and radiotherapy will be assessed according to NCI CTCAE v4.03.
from date of patient consent and up to 20 years after randomization of the last patient
Late radiotherapy-related adverse events
Time Frame: from date of patient consent and up to 20 years after randomization of the last patient
Late adverse events related to the radiotherapy will be assessed according to the Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic (LENT-SOMA) scale
from date of patient consent and up to 20 years after randomization of the last patient
Surgical site infections (SSI)
Time Frame: from date of patient consent and up to 20 years after randomization of the last patient
SSIs will be assessed according to the Centers for Disease Control and Prevention Surgical Site Infection Classification System.
from date of patient consent and up to 20 years after randomization of the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

ETOP IBCSG Partners Foundation
Austrian Breast Cancer Study Group

Investigators

  • Study Chair: Walter P. Weber, Prof., University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 1, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00838; ch20Weber2
  • 2018-000372-14 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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