RecruitingNot ApplicableNCT03513614

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

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)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

1,500 participants

Start Date

Aug 7, 2018

Study Type

INTERVENTIONAL

Conditions

Node-positive Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (TAXIS) is studying a less invasive axillary surgery approach — removing only targeted lymph nodes rather than full lymph node dissection — combined with radiation, in breast cancer patients whose lymph nodes are confirmed cancer-positive. **You may be eligible if...** - You are 18 or older (male or female) with node-positive breast cancer (confirmed by biopsy in both the primary tumor and a lymph node) - You have stage II or III breast cancer of any molecular subtype - The most suspicious lymph node has been clipped (marked) for targeted removal - You have good general health (WHO performance status 0–2) - You may have received or be planning neoadjuvant (pre-surgery) treatment **You may NOT be eligible if...** - You are not a candidate for general anesthesia or breast cancer surgery - You are pregnant or breastfeeding, or not using effective contraception - You have had prior axillary lymph node dissection or axillary radiation (unless this is an isolated breast recurrence after at least 3 years) - Your quality-of-life questionnaire has not been completed at baseline Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETailored axillary surgery - both Arms

Axillary lymph node dissection - Arm A

RADIATIONRadiotherapy - Arm A

Regional nodal irradiation excluding the dissected axilla - Arm A

RADIATIONRadiotherapy - Arm B

Regional nodal irradiation including the full axilla - Arm B

Locations(67)

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

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NCT03513614

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