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.
International Steering Board
| Prof Dr med Thorsten Kühn | The Filderklinik, Filderstadt, Germany and University of Ulm, Ulm, Germany |
| Ass Prof Jana de Boniface | Karolinska Instituet and Capio St Goran Hospital SE – 17176 Stockholm, Sweden +(46) (0)8 5177 0000 |
| Dr Oreste Gentilini | IRCCS San Raffaele Hospital Milan Via Olgettina, 60 20123 Milan, Italy +(39) 02 26433999 |
| Univ Prof Dr med Elmar Stickeler | Universitätsklinikum Aachen Pauwelsstraße 30 52071 Aachen, Germany +(49) 241 90 88400 |
Organizing Committee
| Prof Dr med Thorsten Kühn | The Filderklinik, Filderstadt, Germany and University of Ulm, Ulm, Germany |
| Prof Dr med Maggie Banys Paluchowski | Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein Campus Lubeck Ratzeburger Allee 160 23538 Lubeck, Germany |
| Dr Steffi Hartmann | Department of Gynecology and Obstetrics Klinikum Sudstadt Rostock University of Rostock Sudring 81 18059 Rostock, Germany |
| Dr Marina Mangold | Esculape – Clinical Research Profession Marktstraße 17 35075 Gladenbach |
| Ms Jana Shabbir Study Coordinator | Klinikum Esslingen GmbH Department of Obstetrics and Gynecology Hirschlandstr. 97 73730 Esslingen, Germany Phone: +49 711 / 3103-3063 E-Mail: shabbir@eubreast.com |
| Dr Bilge Aktas International Study Coordinator | EUBREAST e.V Baumreute 37 D 73730 Esslingen, Germany E-Mail: aktas@eubreast.com |
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: Lukas Dostalek
- FINLAND: Dr. Laura Niinikoski
- GERMANY: Priv.-Doz. Dr. Maggie Banys-Paluchowski
- 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
- 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 Study Coordinator: DR BILGE AKTAS SEZEN.
Documents
The following documents are available for download:
Current documents in English:
- Study protocol
- CRF
- SOP Site management
- Subject Identification Log
- Protocol Change Log
- Frequently Asked Questions (FAQ)
- Quality of Life evaluation: User Manual for Study Sites
- eCRF: User Manual for Study Sites
Country-specific documents are available here:
- 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
- Signature & Delegation Log
- Quality of Life Questionnaires – French – paper version only
- Quality of Questionnaires – Dutch – paper version only
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
- 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
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
- International newsletter 03/2022
- German newsletter 10/2022
- International newsletter 10/2022
- German newsletter 02/2022
- International newsletter 02/2022
- German newsletter 08/2021
- International newsletter 04/2021
- German newsletter 04/2021
- International Newsletter 01/2021
- German newsletter 12/2020
- German newsletter 09/2020
Publications
- Applicability of magnetic seeds for target lymph node biopsy after neoadjuvant chemotherapy in initially node‑positive breast cancer patients: data from the AXSANA study
- Axillary staging in node-positive breast cancer converting to node negativity through neoadjuvant chemotherapy: Current evidence and perspectives (sagepub.com)
- Axillary Staging after Neoadjuvant Chemotherapy for Initially Node-Positive BreastCarcinoma in Germany
- GebFra Science: (EN) Axillary Staging after Neoadjuvant Chemotherapy for Initially Node-Positive Breast Carcinoma in Germany Initial Data from the AXSANA study
- GebFra Science: (DE) Axillastaging nach neoadjuvanter Chemotherapie bei initial nodal positivem Mammakarzinom in DeutschlandErste Daten aus der AXSANA-Studie
- 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
- Article in „Frauenarzt“ 9/2020 (in German, Title: Paradigmenwechsel in der Operation der Axilla)
- Article in „Praktische Gynäkologie“ 2/2020 (in German, Title: Targeted axillary dissection)
- Applicability of magnetic seeds for target lymph node biopsy after neoadjuvant chemotherapy in initially node-positive breast cancer patients: data from the AXSANA Study
Conference Proceedings:
- 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) - 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
- EUBREAST at San Antonio Breast Cancer Symposium 2022
- Prospektive, multizentrische Registerstudie zur Bewertung verschiedener axillärer Operationsverfahrennach neoadjuvanter Chemotherapie bei PatientInnen mit initial nodal-positivem Mammakarzinom
- Poster presentation at the San Antonio Breast Cancer Symposium 2021:
Perspectives on axillary management after primary systemic treatment: an international EUBREAST survey - Poster presentation at the San Antonio Breast Cancer Symposium 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.
- Poster presentation at the Symposium of the North-German Society of Gynecology and Obstetrics 2021 by our PhD student (and gynecologist) Franziska Ruf
- Poster at the San Antonio Breast Cancer Symposium 2020
- Presentation at the XXVIII Congress of the Polish Society of Surgical Oncology in Gdansk, Poland (1-3 September 2022)
Videos (including Initiation Video)
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):
The financial support for the AXSANA study has been provided by:
Further, the AXSANA study is supported by:
In case of questions, do not hesitate to contact us at info@eubreast.com
