EUBREAST 03 (R) AXSANA: Axillary surgical techniques after neoadjuvant chemotherapy

Description

AXSANA PI: Thorsten Kühn Study initiated and sponsored by EUBREAST e.V. Trial design: European prospective multicenter registry on axillary surgical techniques after neoadjuvant chemotherapy. Primary endpoint: Invasive disease-free survival, axillary recurrence rate and quality of life and arm morbidity.

As of January 2024, this study was approved to be continued as AXSANA Plus, an unrestricted registry.

International Steering Board

Prof. Dr. med. Thorsten Kühn Principal Investigator	Die Filderklinik Filderstadt-Bonlanden Germany and Klinik für Gynäkologie und Geburtshilfe Universitätsklinikum Ulm, Ulm, Germany
Prof. Dr. med. Maggie Banys-Paluchowski Deputy Principal Investigator	Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein Campus Lübeck Lübeck, Germany
Ass. Prof. Jana de Boniface	Karolinska Instituet and Capio St. Göran’s Hospital Stockholm, Sweden
Prof. Dr. med. Nina Ditsch	University Hospital Augsburg Augsburg, Germany
Prof. Oreste Gentilini	IRCCS San Raffaele Hospital Milan Milan MI Italy
Prof. Dr. Guldeniz Karadeniz Cakmak	Zonguldak BEUN The School of Medicine General Surgery Department Breast and Endocrine Unit Kozlu/Zonguldak 67600 Turkey
Univ – Prof. Dr. med. Elmar Stickeler	Universitätsklinikum Aachen Aachen, German

National Steering Committees

ALBANIA: Prof. Helidon Nina
AUSTRIA: Univ.-Prof. Dr. Florentia Peintinger
BELGIUM: Prof. Dr. Marian Vanhoeij
BULGARIA: Dr. Tsvetomir Ivanov
AZERBAIJAN: Ass. Prof. Hagigat Valiyeva Qanimat
CZECH REPUBLIC: Jan Žatecký
FINLAND: Dr. Laura Niinikoski
GERMANY: PD Dr. med Steffi Hartmann
GREECE: Prof. Dr. Michalis Kontos
INDIA: Dr. Geeta Kadayaprath
ISRAEL: Dr. Douglas Zippel
ITALY: Dott. Oreste Gentilini and Dr. Rosa Di Micco
NORWAY: Dr. Ellen Schlichting
PERU: Lía Pamela Rebaza, MD
POLAND: Prof. Dr. Dawid Murawa
PORTUGAL: Dr. David Pinto
ROMANIA: Dr. Eduard-Alexandru Bonci
SLOVENIA: Andraž Perhavec
SLOVAKIA: Marek Smolár
SPAIN: Dr. Isabel Rubio
SWEDEN: Ass. Prof. Jana de Boniface
SWITZERLAND: Dr. Maria Luisa Gasparri
THAILAND: Dr. Sarun Thongvitokomarn
TURKEY: Prof. Dr. Guldeniz Karadeniz Cakmak
UNITED KINGDOM: Prof. Ashutosh Kothar and Dr. Elina Shaari

eCRF Documentation

The eCRF documentation is available at https://eubreast-axsana.com

In case of questions do not hesitate to contact us at info@eubreast.com or the International Study Coordinator: Katharina Jursik .

Documents

The following documents are available for download:

Current documents in English:

Country-specific documents are available here:

Albania

Signature & Delegation Log
Country not participating in quality of life analysis

Austria

Patient Information and Informed Consent Form [CAVE: for some study sites, this document has been modified slightly according to the requirements of the local ethical committee. Always use the version approved by your local ethical committee!]
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Azerbaijan

Study protocol
Patient Information and Informed Consent Form
Signature & Delegation Log
Country not participating in quality of life analysis

Belgium

Bulgaria

Signature & Delegation Log
Country not participating in quality of life analysis

Czech Republic

Patient Information
Informed Consent Form [CAVE: for some study sites, this document has been modified slightly according to the requirements of the local ethical committee. Always use the version approved by your local ethical committee!]
Patient Information concerning Data Protection
Signature & Delegation Log
Quality of Life Questionnaires – paper version only

Finland

Signature & Delegation Log
Country not participating in quality of life analysis

Germany:

Study protocol
Patient Information and Informed Consent Form [CAVE: for some study sites, this document has been modified slightly according to the requirements of the local ethical committee. Always use the version approved by your local ethical committee!]
CRF
Subject Identification Log
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Greece:

Study protocol
Patient Information and Informed Consent Form
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

India

Signature & Delegation Log
Country not participating in quality of life analysis

Israel

Signature & Delegation Log
Quality of Life Questionnaires – paper version only

Italy:

Study protocol*
Signature & Delegation Log
Subject Identification Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

*Please note that from time to time there are minor redactional changes in the protocol (for example, each time the Sponsor adds a new country and therefore a new Head of Steering Committee). When this occurs, the Sponsor only changes the last number of the Protocol. The last substantial amendment made to the Protocol was Version 5.0 (and therefore, the version approved by the ethical committee of the Coordinating Hospital in Italy). Since that approved version of the Protocol, the Sponsor declares to have only made redactional changes to the names of Heads of Steering Committees (5.0.1, 5.0.2, 5.0.3 and so on).

Norway:

Signature & Delegation Log
Quality of life questionnaires electronic version available on https://data.dynareg.se/axsana

Peru:

Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Poland:

Patient Information and Informed Consent Form
Signature & Delegation Log
Study protocol
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Portugal

Signature & Delegation Log
Quality of life questionnaires – paper version only

Romania:

Study protocol
Patient Information and Informed Consent Form
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Slovakia

Patient Information

Slovenia

Signature & Delegation Log
Country not participating in quality of life analysis

Spain

Patient Information and Informed Consent Form
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Sweden:

Patient Information and Informed Consent Form
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

Switzerland

Patient Information and Informed Consent Form (Italian)
Signature & Delegation Log
Quality of life questionnaires in French – paper version only
Quality of life questionnaires in German – paper version only
Quality of life questionnaires in Italian – paper version only

Thailand

Signature & Delegation Log
Country not participating in quality of life analysis

Turkey

Study protocol
Patient Information and Informed Consent Form
Signature & Delegation Log
Quality of life questionnaires – electronic version available on https://data.dynareg.se/axsana

United Kingdom

Signature & Delegation Log
Quality of life questionnaires – paper version only

AXSANA Newsletters

Publications

Hartmann, S., Banys-Paluchowski, M., Stickeler, E. et al. Applicability of magnetic seeds for target lymph node biopsy after neoadjuvant chemotherapy in initially node-positive breast cancer patients: data from the AXSANA study. Breast Cancer Res Treat 202, 497–504 (2023). https://doi.org/10.1007/s10549-023-07100-0
Banys-Paluchowski, M.; Paluchowski, P; Krawczyk, N.; Praktische Gynäkologie“ 2/2020 (in German, Title: Targeted axillary dissection)
Banys-Paluchowski, M.; Gasparri, M.L.; de Boniface, J.; Gentilini, O.; Stickeler, E.; Hartmann, S.; Thill, M.; Rubio, I.t.; Di Micco, R.; Bonci, E.-A; et al. Surgical Management of the Axilla in Clinically Node-Positive Breast Cancer Patients Converting to Clinical Node Negativity through Neoadjuvant Chemotherapy: Current Status, Knowledge Gaps, and Rationale for the EUBREAST-03 AXSANA Study. Cancers 2021, 13, 1565. https://doi.org/10.3390/cancers13071565
Banys-Paluchowski, M.; Hartmann, S.; de Boniface, J.; Fasching, P.A.; Huebner, H.; Thill, M.; Stickeler, E.; Krawczyk, N.; Blohmer, J.-U.; Solbach, C.; Untch, M.; Ankel, C.; Kühn, T. Paradigmenwechsel in der Operation der Axilla. FRAUENARZT 61 (2020) Nr. 9.
Banys-Paluchowski, M.; de Boniface, J. Axillary staging in node-positive breast cancer converting to node negativity through neoadjuvant chemotherapy: Current evidence and perspectives. Scand J Surg. 2023 Jun;112(2):117-125. Doi: 10.1177/14574969221145892.
Hartmann S, Kühn T, et al. Axillary staging after Neoadjuvant Chemotherapy for Initially Node-Positive Breast Carcinoma in Germany. Geburtsh Frauenheilk 2022; 82:932-940 (2022). Doi: 10.1055/a-1889-7883.
GebFra Science: (DE) Axillastaging nach neoadjuvanter Chemotherapie bei initial nodal positivem Mammakarzinom in DeutschlandErste Daten aus der AXSANA-Studie
Banys-Paluchowski, M., Hartmann, S., et al.: Radar reflectors for marking of target lymph nodes in initially node-positive patients receiving neoadjuvant chemotherapy for breast cancer – a subgroup analysis of the prospective AXSANA (EUBREAST-03) trial. Breast Cancer Res Treat 2025 Feb 20. doi: 10.1007/s10549-025-07635-4.
Hartmann, S., Banys-Paluchowski, M., et al.: Lost axillary markers after neoadjuvant chemotherapy in breast cancer patients – data from the prospective international AXSANA (EUBREAST 3) cohort study (NCT04373655). European Journal of Surgical Oncology 51 (2025) 110253.
Di Micco, R., Hartmann, S., et al.: Diagnostic performance of axillary ultrasound after neoadjuvant chemotherapy in initially node-positive breast cancer patients – results from the prospective AXSANA registry trial. – Eur J Cancer. 2025 Aug 26;226:115607. doi: 10.1016/j.ejca.2025.115607. Epub 2025 Jul 5. PMID: 40645031.
Kühn, T., Banys-Paluchowski, M., Ditsch, N., et al.: Axillary Dissection in Low-Volume Nodal Involvement after Neoadjuvant Therapy in Breast Cancer – BJS, Volume 112, Issue 9, September 2025, znaf180, https://doi.org/10.1093/bjs/znaf180.

Conference Posters and Presentations:

Pappalettera, G.: SGGG, June 26-27, 2025
Bany-Paluchowski, M.: ASCO, Chicago, USA, May 30 – June 3, 2025 – AXSANA Poster Presentation
Schmidt, E.: DGS, June 26-28, 2025 – AXSANA Poster Presentation
EUBREAST at SABCS 2024 – AXSANA/MELODY/SerMa
Gasparri, ML.: Swiss Society of Senology, September, 2024
Bany-Paluchowski, M.: German Senology Conference 2024
Bany-Paluchowski, M.:ASCO, Chicago, USA, 2024 Radar reflectors for marking of target lymph nodes in patients receiving neoadjuvant chemotherapy for breast cancer: a subgroup analysis of the prospective AXSANA (EUBREAST-03) trial
EUBREAST at SABCS 2023 – EUBREAST 1/AXSANA/MELODY/SerMa/I-PREPARE/Neo-ACT/ICARO/SENOMAC
Froelich, S.: DGS, Monaco, Germany, July 6-8, 2023
Ruf, F.:120P: AXSANA (AXillary Surgery After NeoAdjuvant Treatment) EUBREAST-3:
an international prospective multicenter cohort study to evaluate different surgical methods of axillary staging in clinically node-positive
breast cancer patients treated with neoadjuvant chemotherapy (NCT04373655)
Ruf, F: AXSANA – EUBREAST3 (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
Kuehn T.: San Antonio Breast Cancer Symposium Dec 6-8, 2022
Kuehn, T, Murawa, P.: XXVIII Congress of the Polish Society of Surgical Oncology in Gdansk, Poland, 1-3 September 2022
Froelich, S.: DGS Berlin, May 3-5, 2002: Prospektive, multizentrische Registerstudie zur Bewertung verschiedener axillärer Operationsverfahrennach neoadjuvanter Chemotherapie bei PatientInnen mit initial nodal-positivem Mammakarzinom
Ruf, F.: ESMO Breast, Berlin, Germany, May 3-5, 2022
Gasparri, ML.: San Antonio Breast Cancer Symposium Dec 7-11, 2021:
Perspectives on axillary management after primary systemic treatment: an international EUBREAST survey
Kuehn, T: San Antonio Breast Cancer Symposium Dec 7-11, 2021: Axillary Surgery after Neoadjuvant treatment: an international prospective multi center cohort study of the EUBREAST study group to evaluate different surgical methods of axillary staging in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy.
Ruf Franziska, North-German Society of Gynecology and Obstetrics, Lubeck, 2021
Banys-Paluchowski, M.: San Antonio Breast Cancer Symposium, Dec 8-22, 2020
Banys-Paluchowski, M: DGGG Monaco, Germany, Oct 7-10, 2020

Awards

Dr. Eduard-Alexandru Bonci: Executive Unit for Financing Higher Education, Research, Development and Innovation in Romania (UEFISCDI) – Research Results Award Programme Award PN-III-P1-1.1-PRECISI2021-53265 for the article published in Cancers (IF – 6.639 (2020), 5-Year Impact Factor: 6.999 (2020), Q1), “Surgical Management of the Axilla in Clinically Node-Positive Breast Cancer Patients Converting to Clinical Node Negativity through Neoadjuvant Chemotherapy: Current Status, Knowledge Gaps, and Rationale for the EUBREAST-03 AXSANA Study”.
Dr. Sarah Fröhlich: Vortragspreis für Ihre wissenschaftliche Arbeit im Rahmen des 42. Jahreskongress der Deutschen Gesellschaft für Senologie e.V.: “Target Lymph Node Biopsy After Magnetic Seed Marking – First Results oft he AXSANA-Study (NCT04373655).”
Dr. Sarah Fröhlich – Klaus-Dieter-Schulz-Preis für Versorgungsforschung der Deutschen Gesellschaft für Senologie 2024: “Marking of target lymph nodes with clips/coils in breast cancer patients undergoing neoadjuvant chemotherapy – first results from the AXSANA study (NCT04373655).”
Angelika Rief – lecture prize at Deutschen Gesellschaft für Senologie 2024 for the abstract “Marking of Target Lymph Nodes with carbon suspension in breast cancer patients undergoing neoadjuvant chemotherapy – first results from the AXSANA study (NCT04373655)”.
Prof. Dr. Güldeniz Karadaniz: First place scientific award of the Turkish society of Surgery 2024
Dr. Sarah Fröhlich – Vortragspreis der Deutschen Gesellschaft für Senologie 2025: „Surgical axillary staging in elderly patients with initially node-positive breast cancer after neoadjuvant chemotherapy – data from the prospective AXSANA study (NCT04373655 / EUBREAST-03 / AGO-B-053 study)”
PD Dr. Steffi Hartmann – Vortragspreis der Deutschen Gesellschaft für Senologie 2025: “Lost axillary markers after neoadjuvant chemotherapy in breast cancer patients – data from the prospective international AXSANA cohort study (NCT04373655, EUBREAST-03, AGO-B-053)”
Virginia Casati – Prize for outstanding research contributions from the Swiss Society of Gynecology: “Comparison of marking techniques for target lymph nodes in 2,596 patients with node-positive breast cancer treated with neoadjuvant chemotherapy”

Videos (including Initiation Video)

Video: Prof. Dr. med. Thorsten Kühn – SABCS

Video abstract of the AXSANA publication in Cancers 2021
Before study sites start recruiting patients, they are kindly asked to participate in an initiation presentation either via videoconference or by watching the following video (please inform your National Steering Committee afterwards so that your study site can be considered initiated):