Abstract OT1-04-04: AXSANA - EUBREAST 3 (axillary surgery after neoadjuvant treatment): An international prospective multicenter cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655)
Cancer Research, vol. 82, pp. OT1–04
Abstract
Abstract Background The optimal surgical staging procedure of the axilla in patients who convert from a clinically positive (cN+) to a clinically negative node status (ycN0) through neoadjuvant chemotherapy is still controversial. Widely diverse techniques such as full Axillary Lymph Node Dissection (ALND), Targeted Axillary Dissection (TAD), Targeted Lymph Node Biopsy (TLNB) and Sentinel Lymph Node Biopsy alone (SLNB) are given preference in different international guidelines. So far, no comparative data on the oncological outcome or the morbidity of the different procedures are available. Further research is needed to safely de-escalate the extent of axillary surgery in this patient group. Trial design The AXSANA study is an international prospective cohort study including cN+ patients converting to ycN0 status and treated with different axillary staging techniques according to the standard at their treating institution. The study is initiated by the EUBREAST network. The trial includes patients with cT1-4c tumors, who present initially with axillary lymph node metastasis and are scheduled for neoadjuvant chemotherapy. According to an amendment in 2020 the inclusion of patients with highly suspicious nodes without minimally invasive biopsy is allowed. All patients converting to ycN0 status undergo follow-up for 5 years irrespectively of the ypN status. Primary endpoints: Invasive disease-free survival, axillary recurrence rate and health-related quality of life (HRQoL). HRQoL are evaluated using four standardized questionnaires (EORTC QLQ-C 30, EORTC QLQ BR 23, Lymph ICF and SOC-13) at baseline and after 1, 3 and 5 years after surgery. Secondary endpoints are the feasibility and performance of different axillary staging techniques (detection rate, number of removed lymph nodes and association with complications, arm morbidity and quality of life, operating time and use of clinical and economic resources); impact of learning curve, and the detailed mapping of surgical and oncological treatment standards in different countries. The impact on different regional treatment strategies (radiotherapy, ALND) in patients with ypN0(i+), ypN1(mi) and ypN1 is assessed. Current status of the study: On June 30th 157 study sites from 15 countries are open for recruitment (Austria 2, Czech Republic 1, Finland 1, Germany 112, Greece 3, Italy 1, Norway 1, Poland 3, Portugal 5, Romania 2, Russia 1, Sweden 4, Switzerland 4, Spain 6, Turkey 11). 620 patients have been included in the study. Among patients who converted to ycN0 status, 144 have been scheduled for ALND, 157 for TAD and 49 for SLNB. The study is still open for further international study sites. Funding: AGO-B, Claudia-von Schilling Foundation, Ehmann Foundation, AWOgyn, Merit Medical, Endomagnetics, Mammotome Target accrual: 3000 patients worldwide Citation Format: Thorsten Kühn, Steffi Hartmann, Elmar Stickeler, Jana de Boniface, Oreste Gentilini, Sarah Fröhlich, Franziska Ruf, Marc Thill, Michael Hauptmann, Guldeniz Karadeniz Cakmak, Isabel Rubio, Maria Luisa Gasparri, Michaelis Kontos, Eduard-Alexandru Bonci, Laura Niinikoski, Rosa Di Micco, Dawid Murawa, David Pinto, Florentia Peintinger, Christine Solbach, Matilda Appelgren, Jens-Uwe Blohmer, Michael Weigel, Gabriele Kaltenecker, Michael Schrauder, Janine Simons, Marjolein Smidt, Ellen Schlichting, Lukas Dostalek, Alexander Sergeevich Emelyanov, Elisabeth Thiemann, Semra Gunay, Sybille Loibl, Maggie Banys-Paluchowski. AXSANA - EUBREAST 3 (axillary surgery after neoadjuvant treatment): An international prospective multicenter cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging (sentinel lymph node biopsy, targeted axillary dissection, axillary dissection) in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-04-04.
Authors 34
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Klinikum Esslingen GmbH, Esslingen, Germany
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University Hospital Rostock, Department of Gynecology and Obstetrics, Rostock, Germany
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University Hospital Aachen, Department of Gynecology and Obstetrics, Aachen, Germany
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Karolinska Institutet, Department of Moledular Medicine and Surgery, Stockholm, Sweden
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San Raffaele University and Research Hospital, Breast Surgery Unit, Milan, Italy
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University Hospital Rostock, Department of Gynecology and Obstetrics, Rostock, Germany
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University Hospital Schleswig-Holstein
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University Hospital of Schleswig Holstein, Department of Obstetrics and Gynecology, Lübeck, Germany
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AGAPLESION Markus Krankenhaus,Department of Gynecology and Gynecological Oncology, Frankfurt am Main, Germany
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Medizinische Hochschule Brandenburg Theodor Fontane
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Brandenburg Medical School Theodor Fontane, Neuruppin, Germany
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Zonguldak Bülent Ecevit University
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Zonguldak BEUN The School of Medicine, General Surgery Department, Breast and Endocrine Unit, Kozlu/zonguldak, Turkey
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Clinica Universidad de Navarra
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Clínica Universidad de Navarra, Breast Surgical Unit, Madrid, Spain
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Ente Ospedaliero Cantonale, Ospedale Regionale di Lugano, Department of Gynecology and Obstetrics, Lugano, Switzerland
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National and Kapodistrian University of Athens
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Laiko Hospital, National and Kapodistrian University of Athens, 1st Department of Surgery, Athens, Greece
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Institute of Oncology Prof. Dr. Ion Chiricuta
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”Prof. Dr. Ion Chiricuţă” Institute of Oncology, Department of Surgical Oncology, Cluj-Napoca, Romania
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University of Helsinki · Helsinki University Hospital
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Helsinki University Hospital, University of Helsinki, Breast Surgery Unit, Comprehensive Cancer Center, Helsinki, Finland
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San Raffaele University and Research Hospital, Breast Surgery Unit, Milan, Italy
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University of Zielona Góra, Department of General Surgery and Surgical Oncology, Collegium Medicum, Zielona Góra, Poland
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Champalimaud Clinical Center, Champalimaud Foundation, Breast Unit, Lisabon, Portugal
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Medical University of Graz, Institute of Pathology, Graz, Austria
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University of Frankfurt, Department of Gynecology and Obstetrics, Frankfurk am Main, Germany
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Karolonska Institutet, Dept. of Molecular Medicine and Surgery, Stockholm, Sweden
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Charité - Universitätsmedizin Berlin
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Charité Campus Mitte, Department of Gynecology and Breast Cancer Center, Esslingen, Germany
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Leopoldina Krankenhaus Schweinfurt
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Leopoldina Krankenhaus Schweinfurt, Schweinfurt, Germany
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Städtisches Klinikum Karlsruhe
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Städtisches Klinikum Karlsruhe, Karlsruhe, Germany
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Klinikum Aschaffenburg-Alzeneu, Aschaffenburg, Germany
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Maastricht University, GROW – School for Oncology and Developmental Biology, Maastricht, Netherlands
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Affiliation as printed
Maastricht University, GROW – School for Oncology and Developmental Biology, Maastricht, Netherlands
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Oslo University Hospital, Department of Oncology, Oslo, Norway
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Charles University · General University Hospital in Prague
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Charles University, General University Hospital, First Faculty of Medicine, Gynecologic Oncology Center, Department of Obstetrics and Gynecology, Prague, Czech Republic
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Institute of Oncology NN Petrov
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N.N. Petrov NMRC of Oncology, Petersburg, Russian Federation
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Niels-Stensen-Kliniken, Brustzentrum Osnabrück, Osnabrück/Georgsmarienhütte, Germany
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Health Directorate Prof. Dr. Cemil Taşcioğlu City Hospital, Ministry of Health Istanbul Provinicial, Istanbul, Turkey
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GBG – German Breast Group, Neu-Isenburg, Germany
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University Hospital Schleswig-Holstein
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University Hospital of Schleswig Holstein, Campus Lübeck, Department of Obstetrics and Gynecology, Lübeck, Germany
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