Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)
NCT ID: NCT03513614
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2018-08-07
2036-12-31
Brief Summary
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PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALND
Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.
Tailored axillary surgery - both Arms
Axillary lymph node dissection - Arm A
Radiotherapy - Arm A
Regional nodal irradiation excluding the dissected axilla - Arm A
No ALND
Tailored axillary surgery followed by regional nodal irradiation including the full axilla.
Tailored axillary surgery - both Arms
Axillary lymph node dissection - Arm A
Radiotherapy - Arm B
Regional nodal irradiation including the full axilla - Arm B
Interventions
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Tailored axillary surgery - both Arms
Axillary lymph node dissection - Arm A
Radiotherapy - Arm A
Regional nodal irradiation excluding the dissected axilla - Arm A
Radiotherapy - Arm B
Regional nodal irradiation including the full axilla - Arm B
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
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
18 Years
ALL
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Austrian Breast Cancer Study Group
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Walter P. Weber, Prof.
Role: STUDY_CHAIR
University Hospital, Basel, Switzerland
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Duke University/Duke Cancer Center
Durham, North Carolina, United States
Swedish Cancer Institute
Seattle, Washington, United States
Sanatorio Parque Breast Cancer Center
Rosario, Santa Fe Province, Argentina
Institute of Oncology "Angel H. Roffo
Buenos Aires, , Argentina
Krankenhaus Dornbirn
Dornbirn, , Austria
Landeskrankenhaus Feldkirch
Feldkirch, , Austria
Medical University of Innsbruck, Department of Gynecology
Innsbruck, , Austria
Ordens Kinikum Linz, Barmherzige Schwestern
Linz, , Austria
Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU
Salzburg, , Austria
Medizinische Universität Wien - Klinik für Chirurgie
Vienna, , Austria
Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
Vienna, , Austria
Hanusch Hospital Vienna
Vienna, , Austria
Klinikum Wels-Grieskrichen GmbH
Wels, , Austria
CIUSSS du Centre Ouest-de-l'Île-de-Montréal, Jewish General Hospital
Montreal, , Canada
Breast Centre of Clinical Hospital
Rijeka, , Croatia
HRUHC Sestre milosdrnice
Zagreb, , Croatia
Ev. Waldkrankenhaus Spandau
Berlin, , Germany
KEM | Evang. Kliniken Essen-Mitte gGmbH
Essen, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Georgsmarienhütte, , Germany
Universitätsklinikum Heidelberg, Sektion Senologie
Heidelberg, , Germany
ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus
Karlsruhe, , Germany
Onkologie Rheinsieg
Troisdorf, , Germany
Helios University Hospital Wuppertal
Wuppertal, , Germany
Attikon University Hospital
Chaïdári, Athens, Greece
University Hospital of Heraklion
Heraklion, Crete, Greece
Alexandra General Hospital
Athens, , Greece
Larissa General University Hospital
Larissa, , Greece
Iaso Maternity Hospital
Marousi, , Greece
Athens Medical Center Iatriko
Marousi, , Greece
University Hospital of Patras
Pátrai, , Greece
National Institute of Oncology
Budapest, , Hungary
Bacs-Kiskun Country Hospital
Kecskemét, , Hungary
University of Szeged
Szeged, , Hungary
Ospedale MultiMedica Castellanza
Castellanza, , Italy
Fondazione Policlinico Universitario "Agostino Gemelli" di Roma
Rome, , Italy
Pauls Stradinš Clinical University Hospital
Riga, , Latvia
National Cancer Institut
Vilnius, , Lithuania
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Kantonsspital Aarau
Aarau, , Switzerland
Brustzentrum Basel und Netzwerk
Allschwil, , Switzerland
Kantonsspital Baden
Baden, , Switzerland
Universitätsspital Basel
Basel, , Switzerland
Bethesda Spital Basel, Gynäkologie und Geburtshilfe
Basel, , Switzerland
St. Claraspital AG
Basel, , Switzerland
Brustzentrum Bern, Lindenhofgruppe Centerclinic
Bern, , Switzerland
Clinique de Grangettes
Chêne-Bougeries, , Switzerland
Kantonsspital Graubünden
Chur, , Switzerland
Brustzentrum Thurgau
Frauenfeld, , Switzerland
Breast center Fribourg
Fribourg, , Switzerland
HUG - Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Clinique de Genolier
Genolier, , Switzerland
Hôpital Neuchâtelois
La Chaux-de-Fonds, , Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, , Switzerland
Luzerner Kantonsspital - Brustzentrum
Lucerne, , Switzerland
Hirslanden Klinik St. Anna
Lucerne, , Switzerland
Centro di Senologia della Svizzera Italiana CSSI
Lugano, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Tumor-and Breast centre Ostschweiz
Sankt Gallen, , Switzerland
Spital Limmattal
Schlieren, , Switzerland
Hôpital du Valais / Hôpital de Sion
Sion, , Switzerland
Kantonsspital Winterthur, Brustzentrum
Winterthur, , Switzerland
Spital Zollikerberg
Zollikerberg, , Switzerland
Brust-Zentrum Zürich (Seefeld)
Zurich, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Universitäts Spital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2018-000372-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2018-00838; ch20Weber2
Identifier Type: -
Identifier Source: org_study_id
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