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

NCT03513614 | Active Not Recruiting DMC

• 2 other identifiers: 2018-00838; ch20Weber22018-000372-14
• Study Type: interventional
• Target: 1,500
• Locations: 13 countries
• Sites: 64

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

Conditions

Node-positive Breast Cancer

Keywords

Tailored Axillary Surgery; TAXIS; Breast Cancer; node-positive breast cancer; phase III trial; IBCSG 57-18; ABCSG

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Overall survival (OS)

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

• Breast cancer-specific survival (BCSS)

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

• Time to local recurrence (TTLR)

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

• Time to distant recurrence (TTDR)

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

• Physician reported morbidity outcomes (Lymphedema)

  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.

Study Arms (2)

ALND

ACTIVE COMPARATOR

Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.

Procedure: Tailored axillary surgery - both Arms; Radiation: Radiotherapy - Arm A

No ALND

ACTIVE COMPARATOR

Tailored axillary surgery followed by regional nodal irradiation including the full axilla.

Procedure: Tailored axillary surgery - both Arms; Radiation: Radiotherapy - Arm B

Interventions

Tailored axillary surgery - both Arms PROCEDURE

Axillary lymph node dissection - Arm A

ALND; No ALND

Radiotherapy - Arm A RADIATION

Regional nodal irradiation excluding the dissected axilla - Arm A

ALND

Radiotherapy - Arm B RADIATION

Regional nodal irradiation including the full axilla - Arm B

No ALND

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• ETOP IBCSG Partners Foundation: collaborator
• Austrian Breast Cancer Study Group: collaborator

Study Sites (64)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Duke University/Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Sanatorio Parque Breast Cancer Center

Rosario, Santa Fe Province, S2000, Argentina

Location

Institute of Oncology "Angel H. Roffo

Buenos Aires, C1417, Argentina

Location

Krankenhaus Dornbirn

Dornbirn, 6850, Austria

Location

Landeskrankenhaus Feldkirch

Feldkirch, 6800, Austria

Location

Medical University of Innsbruck, Department of Gynecology

Innsbruck, 6020, Austria

Location

Ordens Kinikum Linz, Barmherzige Schwestern

Linz, 4010, Austria

Location

Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU

Salzburg, 5020, Austria

Location

Medizinische Universität Wien - Klinik für Chirurgie

Vienna, 1090, Austria

Location

Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde

Vienna, 1090, Austria

Location

Hanusch Hospital Vienna

Vienna, 1140, Austria

Location

Klinikum Wels-Grieskrichen GmbH

Wels, 4600, Austria

Location

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

Montreal, 3755, Canada

Location

Breast Centre of Clinical Hospital

Rijeka, 51000, Croatia

Location

HRUHC Sestre milosdrnice

Zagreb, Croatia

Location

KEM | Evang. Kliniken Essen-Mitte gGmbH

Essen, 45136, Germany

Location

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

Georgsmarienhütte, 49124, Germany

Location

Universitätsklinikum Heidelberg, Sektion Senologie

Heidelberg, 69120, Germany

Location

ViDia Christliche Kliniken Karlsruhe, Diakonissenkrankenhaus

Karlsruhe, 76199, Germany

Location

Helios University Hospital Wuppertal

Wuppertal, 42283, Germany

Location

Attikon University Hospital

Chaïdári, Athens, 124 62, Greece

Location

University Hospital of Heraklion

Heraklion, Crete, 71500, Greece

Location

Alexandra General Hospital

Athens, 115 28, Greece

Location

Larissa General University Hospital

Larissa, 413 34, Greece

Location

Iaso Maternity Hospital

Marousi, 151 23, Greece

Location

Athens Medical Center Iatriko

Marousi, 151 25, Greece

Location

University Hospital of Patras

Pátrai, 265 04, Greece

Location

National Institute of Oncology

Budapest, 1122, Hungary

Location

Bacs-Kiskun Country Hospital

Kecskemét, 6000, Hungary

Location

University of Szeged

Szeged, 6720, Hungary

Location

Ospedale MultiMedica Castellanza

Castellanza, 21053, Italy

Location

Fondazione Policlinico Universitario "Agostino Gemelli" di Roma

Rome, 00168, Italy

Location

Pauls Stradinš Clinical University Hospital

Riga, 1002, Latvia

Location

National Cancer Institut

Vilnius, 08406, Lithuania

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

Brustzentrum Basel und Netzwerk

Allschwil, 4123, Switzerland

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Bethesda Spital Basel, Gynäkologie und Geburtshilfe

Basel, 4052, Switzerland

Location

Brustzentrum Bern, Lindenhofgruppe Centerclinic

Bern, 3011, Switzerland

Location

Clinique de Grangettes

Chêne-Bougeries, 1224, Switzerland

Location

Kantonsspital Graubünden

Chur, 7000, Switzerland

Location

Brustzentrum Thurgau

Frauenfeld, 8501, Switzerland

Location

Breast center Fribourg

Fribourg, 1700, Switzerland

Location

HUG - Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

Location

Clinique de Genolier

Genolier, 1272, Switzerland

Location

Hôpital Neuchâtelois

La Chaux-de-Fonds, 2300, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

Location

Luzerner Kantonsspital - Brustzentrum

Lucerne, 6000, Switzerland

Location

Hirslanden Klinik St. Anna

Lucerne, 6006, Switzerland

Location

Centro di Senologia della Svizzera Italiana CSSI

Lugano, 6970, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9000, Switzerland

Location

Tumor-and Breast centre Ostschweiz

Sankt Gallen, 9016, Switzerland

Location

Spital Limmattal

Schlieren, 8952, Switzerland

Location

Hôpital du Valais / Hôpital de Sion

Sion, 1950, Switzerland

Location

Kantonsspital Winterthur, Brustzentrum

Winterthur, 8401, Switzerland

Location

Spital Zollikerberg

Zollikerberg, 8125, Switzerland

Location

Brust-Zentrum Zürich (Seefeld)

Zurich, 8008, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Universitäts Spital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 34555676 RESULT

• 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.

  PMID: 37903951 DERIVED

• 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.

  PMID: 37355526 DERIVED

• 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.

  PMID: 30514362 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Walter P. Weber, Prof.

  University Hospital, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: August 7, 2018
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2036
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

KR (2); CR (2); AR (2); GR (7); DE (5); IT (2); LI (1); CH (26); AU (9); HU (3); LA (1); US (3); CA (1)