AXillary Surgery After NeoAdjuvant Treatment
A prospective multicenter cohort study 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
Based on the lack of sufficient evidence and discrepancies between different national and institutional standards, EUBREAST decided to initiate a prospective cohort study as an international project that aims at comparatively evaluating data on axillary staging after neoadjuvant therapy. Since AXSANA aims at analyzing the clinical landscape of axillary surgery, study sites participating in the AXSANA are free to use any technique they choose.
Below please find:
Country-specific Documents For Download
AXSANA Videos (Including Initiation Video in English)
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 Coordinartor: DR BILGE AKTAS SEZEN.
If you wish to participate in AXSANA, please contact your National Steering Committee:
- ALBANIA: Prof. Helidon Nina, ninahelios@yahoo.com
- AUSTRIA: Univ.-Prof. Dr. Florentia Peintinger, florentia.peintinger@medunigraz.at
- BELGIUM: Prof. Dr. Marian Vanhoeij, Marian.vanhoeij@uzbrussel.be
- BULGARIA: Dr. Tsvetomir Ivanov, tsvetomirmiroslavovivanov@gmail.com
- AZERBAIJAN: Ass. Prof. Hagigat Valiyeva Qanimat, hagigatvaliyeva@icloud.com
- CZECH REPUBLIC: Lukas Dostalek, lukas.dostalek@vfn.cz
- FINLAND: Dr. Laura Niinikoski, laura.niinikoski@hus.fi
- FRANCE: Prof. Dr. Jean-Marc Classe, jean-marc.classe@ico.unicancer.fr
- GERMANY: Priv.-Doz. Dr. Maggie Banys-Paluchowski, m.banys@outlook.com
- GREECE: Prof. Dr. Michalis Kontos, michalis_kontos@yahoo.com
- HONG KONG: Dr. Sara Wai-Wun Fung, wun.sara@gmail.com
- HUNGARY: Dr. habil. Zoltan Matrai, matraidoc@gmail.com
- INDIA: Dr. Geeta Kadayaprath, geeta.kadayaprath@maxhealthcare.com
- ISRAEL: Dr. Douglas Zippel, Dov.Zippel@sheba.health.gov.il
- ITALY: Dott. Oreste Gentilini, gentilini.oreste@hsr.it and Dr. Rosa Di Micco, dimicco.rosa@hsr.it
- MEXICO: Arturo Pabel Miranda-Aguirre, drpabelm@hotmail.com
- NORWAY: Dr. Ellen Schlichting, elschl@ous-hf.no
- PERU: Lía Pamela Rebaza, MD, rebazavasquezlia@gmail.com
- POLAND: Prof. Dr. Dawid Murawa, d.murawa@gmail.com
- PORTUGAL: Dr. David Pinto, david.pinto@fundacaochampalimaud.pt
- ROMANIA: Dr. Eduard-Alexandru Bonci, bonci.eduard@gmail.com
- RUSSIA: Prof. Dr. Petr Krivorotko, dr.krivorotko@mail.ru and Dr. Emelyanov Alexander Sergeevich, ae28111992@yandex.ru
- SLOVENIA: Andraž Perhavec, aperhavec@onko-i.si
- SPAIN: Dr. Isabel Rubio, irubior@unav.es
- SWEDEN: Ass. Prof. Jana de Boniface, jana.de-boniface@ki.se
- SWITZERLAND: Dr. Maria Luisa Gasparri, MariaLuisa.Gasparri@eoc.ch
- THAILAND: Dr. Sarun Thongvitokomarn, sarun.t@chulahospital.org
- TURKEY: Prof. Dr. Guldeniz Karadeniz Cakmak, gkkaradeniz@yahoo.com
- UNITED KINGDOM: Prof. Ashutosh Kothari, Ashutosh.Kothari@gstt.nhs.uk | Dr. Elina Shaari, Elina.Shaari@gstt.nhs.uk
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
- 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
- Study protocol
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Signature & Delegation Log
- Quality of Life Questionnaires - French - paper version only
- Quality of Questionnaires - Dutch - paper version only
- Signature & Delegation Log
- Country not participating in quality of life analysis
- 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
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Quality of life questionnaires - paper version only
- 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
- Study protocol
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Signature & Delegation Log
- Quality of Life Questionnaires - paper version only
- 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).
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- 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
- Study protocol
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- Study protocol
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- 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 - electronic version available on https://data.dynareg.se/axsana
- Quality of life questionnaires in Italian - electronic version available on https://data.dynareg.se/axsana
- Signature & Delegation Log
- Country not participating in quality of life analysis
- Study protocol
- Patient Information and Informed Consent Form
- Signature & Delegation Log
- Quality of life questionnaires - electronic version available on https://data.dynareg.se/axsana
- International newsletter 3/2023
- 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
- 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
- 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)
- 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
-
nach 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 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
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):
Initiation video in English
Initiation video in German:
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
