AzTrials
AzTrials

Node-positive Breast CancerTAXISNCT03513614

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

A study testing Tailored axillary surgery - both Arms, Radiotherapy - Arm A and Radiotherapy - Arm B in people with Node-positive Breast Cancer, run by University Hospital, Basel, Switzerland at 64 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Node-positive Breast Cancer
What is being tested?
Tailored axillary surgery - both Arms, Radiotherapy - Arm A and Radiotherapy - Arm B
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
64 sitesin 13 countries
Study dates
7 Aug 2018to Dec 2036
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.
  • 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
  • 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
Show all 21Show fewer
  • 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.
  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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.
  • 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

Trial locations and contacts

64 sites in 13 countries.

64 sites in 13 countries

Switzerland26 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Brustzentrum Basel und Netzwerk

    Allschwil, 4123

  • Kantonsspital Baden

    Baden, 5404

  • Universitätsspital Basel

    Basel, 4031

  • Bethesda Spital Basel, Gynäkologie und Geburtshilfe

    Basel, 4052

  • Brustzentrum Bern, Lindenhofgruppe Centerclinic

    Bern, 3011

  • Clinique de Grangettes

    Chêne-Bougeries, 1224

  • Kantonsspital Graubünden

    Chur, 7000

  • Brustzentrum Thurgau

    Frauenfeld, 8501

  • Breast center Fribourg

    Fribourg, 1700

  • HUG - Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Clinique de Genolier

    Genolier, 1272

  • Hôpital Neuchâtelois

    La Chaux-de-Fonds, 2300

  • Centre Hospitalier Universitaire Vaudois CHUV

    Lausanne, 1011

  • Luzerner Kantonsspital - Brustzentrum

    Lucerne, 6000

  • Hirslanden Klinik St. Anna

    Lucerne, 6006

  • Centro di Senologia della Svizzera Italiana CSSI

    Lugano, 6970

  • Kantonsspital St. Gallen

    Sankt Gallen, 9000

  • Tumor-and Breast centre Ostschweiz

    Sankt Gallen, 9016

  • Spital Limmattal

    Schlieren, 8952

  • Hôpital du Valais / Hôpital de Sion

    Sion, 1950

  • Kantonsspital Winterthur, Brustzentrum

    Winterthur, 8401

  • Spital Zollikerberg

    Zollikerberg, 8125

  • Brust-Zentrum Zürich (Seefeld)

    Zurich, 8008

  • Stadtspital Triemli

    Zurich, 8063

  • Universitäts Spital Zürich

    Zurich, 8091

Other trials in Switzerland

Austria9 sites

  • Krankenhaus Dornbirn

    Dornbirn, 6850

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6800

  • Medical University of Innsbruck, Department of Gynecology

    Innsbruck, 6020

  • Ordens Kinikum Linz, Barmherzige Schwestern

    Linz, 4010

  • Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU

    Salzburg, 5020

  • Medizinische Universität Wien - Klinik für Chirurgie

    Vienna, 1090

  • Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde

    Vienna, 1090

  • Hanusch Hospital Vienna

    Vienna, 1140

  • Klinikum Wels-Grieskrichen GmbH

    Wels, 4600

Other trials in Austria

Greece7 sites

  • Alexandra General Hospital

    Athens, 115 28

  • Attikon University Hospital

    Chaïdári, Athens, 124 62

  • University Hospital of Heraklion

    Heraklion, Crete, 71500

  • Larissa General University Hospital

    Larissa, 413 34

  • Iaso Maternity Hospital

    Marousi, 151 23

  • Athens Medical Center Iatriko

    Marousi, 151 25

  • University Hospital of Patras

    Pátrai, 265 04

Other trials in Greece

Germany5 sites

  • KEM | Evang. Kliniken Essen-Mitte gGmbH

    Essen, 45136

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

    Georgsmarienhütte, 49124

  • Universitätsklinikum Heidelberg, Sektion Senologie

    Heidelberg, 69120

  • ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus

    Karlsruhe, 76199

  • Helios University Hospital Wuppertal

    Wuppertal, 42283

Other trials in Germany

United States3 sites

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814

  • Duke University/Duke Cancer Center

    Durham, North Carolina, 27710

  • Swedish Cancer Institute

    Seattle, Washington, 98104

Other trials in United States

Hungary3 sites

  • National Institute of Oncology

    Budapest, 1122

  • Bacs-Kiskun Country Hospital

    Kecskemét, 6000

  • University of Szeged

    Szeged, 6720

Other trials in Hungary

Argentina2 sites

  • Institute of Oncology "Angel H. Roffo

    Buenos Aires, C1417

  • Sanatorio Parque Breast Cancer Center

    Rosario, Santa Fe Province, S2000

Other trials in Argentina

Croatia2 sites

  • Breast Centre of Clinical Hospital

    Rijeka, 51000

  • HRUHC Sestre milosdrnice

    Zagreb

Other trials in Croatia

Italy2 sites

  • Ospedale MultiMedica Castellanza

    Castellanza, 21053

  • Fondazione Policlinico Universitario "Agostino Gemelli" di Roma

    Rome, 00168

Other trials in Italy

South Korea2 sites

  • Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Canada1 site

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

    Montreal, 3755

Other trials in Canada

Latvia1 site

  • Pauls Stradinš Clinical University Hospital

    Riga, 1002

Other trials in Latvia

Lithuania1 site

  • National Cancer Institut

    Vilnius, 08406

Other trials in Lithuania

About this study

Official title: 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.

Read the 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.

Being tested
Tailored axillary surgery - both Arms, Radiotherapy - Arm A, Radiotherapy - Arm B
Keywords
Tailored Axillary Surgery, TAXIS, Breast Cancer, node-positive breast cancer, phase III trial, IBCSG 57-18, ABCSG
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Tailored axillary surgery - both ArmsProcedure or surgery

    Axillary lymph node dissection - Arm A

  • Radiotherapy - Arm ARadiation

    Regional nodal irradiation excluding the dissected axilla - Arm A

  • Radiotherapy - Arm BRadiation

    Regional nodal irradiation including the full axilla - Arm B

Study groups in NCT03513614
Study groupRoleWhat they receive
ALNDActive comparatorTailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.
Receives: Procedure: Tailored axillary surgery - both Arms; Radiation: Radiotherapy - Arm A
No ALNDActive comparatorTailored axillary surgery followed by regional nodal irradiation including the full axilla.
Receives: Procedure: Tailored axillary surgery - both Arms; Radiation: Radiotherapy - Arm B

What is being measured

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

  1. Disease-free survival (DFS)

    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.

    Measured: at the occurrence of the event or latest 20 years after randomization of the last patient

Secondary outcomes (9)

  1. Overall survival (OS)

    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.

    Measured: at the occurrence of the event or latest 20 years after randomization of the last patient

  2. Breast cancer-specific survival (BCSS)

    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.

    Measured: at the occurrence of the event or latest 20 years after randomization of the last patient

  3. Time to local recurrence (TTLR)

    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.

    Measured: at the occurrence of the event or latest 20 years after randomization of the last patient

  4. Time to distant recurrence (TTDR)

    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.

    Measured: at the occurrence of the event or latest 20 years after randomization of the last patient

  5. Physician reported morbidity outcomes (Lymphedema)

    Measured: 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.

  6. Physician reported morbidity outcomes (Decreased range of shoulder motion)

    Measured: 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.

  7. Adverse events according to NCI CTCAE v4.03

    Clipping-related AEs and specific AEs related to the surgical procedure and radiotherapy will be assessed according to NCI CTCAE v4.03.

    Measured: from date of patient consent and up to 20 years after randomization of the last patient

  8. Late radiotherapy-related adverse events

    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

    Measured: from date of patient consent and up to 20 years after randomization of the last patient

  9. Surgical site infections (SSI)

    SSIs will be assessed according to the Centers for Disease Control and Prevention Surgical Site Infection Classification System.

    Measured: from date of patient consent and up to 20 years after randomization of the last patient

Timeline

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

  1. First posted1 May 2018
  2. Study start7 Aug 2018
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2036 (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
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513614
Sponsor's protocol ID
2018-00838; ch20Weber2
Other IDs
2018-000372-14, 2018
Acronym
TAXIS
Status last verified
Apr 2026
First submitted
19 Apr 2018
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Weber WP, Matrai Z, Hayoz S, Tausch C, Henke G, Zwahlen DR, Gruber G, Zimmermann F, Seiler S, Maddox C, Ruhstaller T, Muenst S, Ackerknecht M, Kuemmel S, Bjelic-Radisic V, Kurzeder C, Ujhelyi M, Vrieling C, Satler R, Meyer I, Becciolini C, Bucher S, Simonson C, Fehr PM, Gabriel N, Maraz R, Sarlos D, Dedes KJ, Leo C, Berclaz G, Dubsky P, Exner R, Fansa H, Hager C, Reisenberger K, Singer CF, Reitsamer R, Reinisch M, Winkler J, Lam GT, Fehr MK, Naydina T, Kohlik M, Clerc K, Ostapenko V, Fitzal F, Nussbaumer R, Maggi N, Schulz A, Markellou P, Lelievre L, Egle D, Heil J, Knauer M. Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101). Breast. 2021 Dec;60:98-110. doi: 10.1016/j.breast.2021.09.004. Epub 2021 Sep 8.

    PubMed 34555676

  • Weber WP, Heidinger M, Hayoz S, Matrai Z, Tausch C, Henke G, Zwahlen DR, Gruber G, Zimmermann F, Montagna G, Andreozzi M, Goldschmidt M, Schulz A, Mueller A, Ackerknecht M, Tampaki EC, Bjelic-Radisic V, Kurzeder C, Savolt A, Smanyko V, Hagen D, Muller DJ, Gnant M, Loibl S, Fitzal F, Markellou P, Bekes I, Egle D, Heil J, Knauer M. Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101). Ann Surg Oncol. 2024 Jan;31(1):344-355. doi: 10.1245/s10434-023-14404-4. Epub 2023 Oct 30.

    PubMed 37903951

  • Tausch C, Daster K, Hayoz S, Matrai Z, Fitzal F, Henke G, Zwahlen DR, Gruber G, Zimmermann F, Andreozzi M, Goldschmidt M, Schulz A, Maggi N, Saccilotto R, Heidinger M, Mueller A, Tampaki EC, Bjelic-Radisic V, Savolt A, Smanyko V, Hagen D, Muller DJ, Gnant M, Loibl S, Markellou P, Bekes I, Egle D, Ruhstaller T, Muenst S, Kuemmel S, Vrieling C, Satler R, Becciolini C, Bucher S, Kurzeder C, Simonson C, Fehr PM, Gabriel N, Maraz R, Sarlos D, Dedes KJ, Leo C, Berclaz G, Fansa H, Hager C, Reisenberger K, Singer CF, Montagna G, Reitsamer R, Winkler J, Lam GT, Fehr MK, Naydina T, Kohlik M, Clerc K, Ostapenko V, Lelievre L, Heil J, Knauer M, Weber WP. Trends in use of neoadjuvant systemic therapy in patients with clinically node-positive breast cancer in Europe: prospective TAXIS study (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101). Breast Cancer Res Treat. 2023 Sep;201(2):215-225. doi: 10.1007/s10549-023-06999-9. Epub 2023 Jun 25.

    PubMed 37355526

  • Henke G, Knauer M, Ribi K, Hayoz S, Gerard MA, Ruhstaller T, Zwahlen DR, Muenst S, Ackerknecht M, Hawle H, Fitzal F, Gnant M, Matrai Z, Ballardini B, Gyr A, Kurzeder C, Weber WP. Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial. Trials. 2018 Dec 4;19(1):667. doi: 10.1186/s13063-018-3021-9.

    PubMed 30514362

Questions about this trial

What is this clinical trial studying?

A study testing Tailored axillary surgery - both Arms, Radiotherapy - Arm A and Radiotherapy - Arm B in people with Node-positive Breast Cancer, run by University Hospital, Basel, Switzerland at 64 sites in 13 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 21 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Switzerland, Austria, Greece, Germany, United States and 8 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (DFS) (time frame: at the occurrence of the event or latest 20 years after randomization of the last patient). 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 NCT03513614, which also lists 4 linked publications.

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 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in