Trials & Projects
EUBREAST 06 (R) OMA (in cooperation with OPBC)
EUBREAST 07 (E) Webinar series 2021
EUBREAST 09 (E) OPBC / Toolbox / EUBREAST consensus conference 1 on lymph node management
EUBREAST 10 (E) OPBC / Toolbox / EUBREAST consensus conference 2 on lymph node management
EUBREAST 12 (E) EUBREAST Educational Project
EUBREAST 13 (R) UEMS - EUBREAST Breast Care Survey
EUBREAST 01 (R): Omission of sentinel lymph node biopsy in triple-negative and HER2-positive breast cancer patients with radiologic and pathologic complete response in the breast after neoadjuvant systemic therapy: a single-arm, prospective surgical trial.
- PI: Oreste Gentilini, Toralf Reimer
- study initiated by EUBREAST
- trial design: prospective, multi-center, single-arm (triple-negative and HER2-positive breast cancer)
- primary endpoint: 3-year axillary recurrence-free survival (ARFS) after neoadjuvant systemic therapy and lumpectomy (BCS) in initially cN0 patients
EUBREAST 02 (R) International Survey on breast cancer management in the Covid 19 era
Topic: Changes in breast cancer management during the Corona Virus Disease 19 pandemic
PI: Maria Luisa Gasparri
Core team: ML Gasparri, OD Gentilini, D Lueftner, T Kuehn, O Kaidar-Person, P Poortmans
Supporting societies:
- European Breast Cancer Research Association of Surgical Trialists (Eubreast)
- European Society of Breast Cancer Specialists (EUSOMA)
- Associazione Nazionale Italiana Senologi Chirurghi (ANISC)
- British Association of Breast Surgeons (ABS)
- Oncoplastic Breast Consortium (OPBC)
- Association for Gynecological Oncology / Arbeitsgemeinschaft Gynaekolocische Onkologie (AGO)
- Scuola Italiana di Senologia
- Collegio dei Senologi Italiani
- Società Svizzera di Senologia/Schweizerische Gesellschaft fuer Senologie/ Societè suisse de Senologie
- Polish Society of Surgical Oncology
- Central Eastern European Breast Cancer Surgical Consortium (CEEBCSC)
- German Cancer Association / Deutsches Krebsgesellschaft
- Hellenic Breast Surgical Society
- Russian Association of Oncological Mammology
- Senaturk
Study design: international web-survey
Brief presentation: Breast cancer management was considerably modified during the COVID-19 pandemic. This was the first, fastest, and largest survey among breast specialists investigating this topic and showing a snapshot on the international discrepancies. In ten days, 377 breast units from 41 countries adhered and responded our questionnaire.
Full publication available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256546/pdf/main.pdf
EUBREAST 03 (R) AXSANA
- PI: Thorsten Kühn
- study initiated and sponsored by EUBREAST
- 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
EUBREAST 04 (R) MELODY
- PI: Maggie Banys-Paluchowski
- Study initiated by EUBREAST
- Trial design: International non-interventional study on different localization methods for non-palpable malignant breast lesions
- Primary endpoint: Negative resection margin rates at primary surgery in patients with invasive breast cancer, stratified by the localization technique
EUBREAST 05 (R) SERMA (Seroma of the Mammary gland)
- PI: Prof. Dr. Nina Ditsch
- Study supported by EUBREAST
- Trial design: Trial design: Prospective, interventional, multicenter non-AMG/MPG study to detect possible markers for prediction and risk assessment of a breast seroma after skin-sparing mastectomy and implant breast reconstruction
- Primary endpoint: Discovery of immune markers for risk assessment of developing a seroma, analysis of the microbiome diversity and differentiation between a specific immune reaction and a general infection in development of a seroma.
EUBREAST 06 (R) OMA (in cooperation with OPBC)
- PI: Giacomo Montagna
- study supported by EUBREAST
- trial design: multicenter retrospective cohort study - nodal recurrence following axillary downstaging with neoadjuvant chemotherapy and omission of axillary lymph node dissection
- primary endpoint: rate of nodal recurrence
EUBREAST 07 (E) Webinar Series
- webinars available here for viewing
EUBREAST 08 (R) International Survey on lymph node management in node positive breast cancer patients after neoadjuvant chemotherapy
Topic:International discrepancies on the axillary management amongradiation oncologists and breast surgeons
PI: Maria Luisa Gasparri
Core team: M.L. Gasparri, J. de Boniface, P. Poortmans, T. Kühn, O.D. Gentilini, O. Kaidar-Person
Supporting societies:
- European Breast Cancer Research Association of Surgical Trialists (Eubreast)
- American Society of Breast Surgeons
- Arbeitsgemeinschaft für gynäkologische Onkologie
- Associazione Nazionale Italiana Senologi Chirurghi
- Collegio Italiano dei Senologi
- Deutsche Gesellschaft für Radioonkologie
- Deutsche Gesellschaft für Senologie
- Global Breast Hub
- Israel Breast Surgeons Society
- Israel Radiation Therapy society
- Swiss Society of Senology
- Scuola Italiana di Senologia
- Società Polispecialistica Italiana Giovani Chirurghi
- Swedish Breast Cancer Group
- The Oncoplastic Breast Consortium
Study design: international web-survey
Brief presentation: There is no consensus on the axillary management following primary systemic treatment in clinically node-positive breast cancer patients. The discrepancies in the breast surgical and radiation therapy approaches have been «quantified» testing a representative sample of 349 breast surgeons and radiation oncologists from 45 countries. The resulted heterogeneity among countries and centres, reinforces the rationale of the ongoing AXSANA (EUBREAST-3) study.
Full publication: Not yet available
EUBREAST 09 (E) OPBC / Toolbox / EUBREAST consensus conference 1 on lymph node management
Upcoming event: September 1st 2022, 13:00 - 17:00 CET
Protocol on first phase of the OPBC 2022 / EUBREAST / Toolbox2 Project (pdf)
Protocol on first phase of the OPBC 2022 / EUBREAST / Toolbox2 Project (docx)
EUBREAST 10 (E) OPBC / Toolbox / EUBREAST consensus conference 2 on lymph node management
EUBREAST 11 (R) I-PREPARE
- Study PI: Oreste Gentilini
- Study initiated by EUBREAST
- Trial Design: International prospective cohort study that aims at comparatively evaluating data on different surgical techniques of
pre-pectoral breast reconstruction with or without radiation - Primary Endpoint: Implant-loss at three months postoperatively defined as the unplanned removal
or loss of the implant as a result of infection or other complication
EUBREAST 12 (E) EUBREAST EDUCATIONAL PROJECT (more info to follow)
EUBREAST 13 (R) UEMS - EUBREAST Breast Care Survey
Topic: Breast Care Specialists Training
Core Team: Prof. Florentia Peintinger, Prof. Thorsten Kuehn, Dr. Med. dr. Phil. Maria Luisa Gasparri, Dr. Angelika Rief
Study Design: International, multidisplicinary online survey
Brief Presentation: The European Union of Medical Specialists (UEMS-Multidisciplinary Joint Committee Breast Care) and the European Breast Cancer Research Association of Surgical Trialists (EUBREAST) aim to evaluate the training of breast care specialists across Europe and abroad. This survey should provide an incentive for international harmonization and quality improvement.
Click here: Link to Breast Care Survey
Trials supported by EUBREAST
Completed Trials
AGO 35
- PI: Florentia Peintinger
- study supported by EUBREAST
- trial design: prospective observational trail
- primary endpoint: probability of achieving a negative axillary node status. Prospective validation of genomic signatures to predict treatment response in the axillary nodes after neoadjuvant chemotherapy in patients with HER2-negative breast cancer.
TATTOO-Study: Tattooing suspicious axillary lymph nodes in breast cancer patients treated by primary systemic therapy
- PI: Steffi Hartmann (MD)
- study initiated by EUBREAST
- Kind of trial: prospective feasibility trial
- Primary study endpoint: Detection rate of charcoal tattooed axillary lymph nodes during surgery after primary systemic therapy in breast cancer patients.
SOUND: Sentinel node vs Observation after axillary Ultra-souND
- PI: Oreste Gentilini
- study supported by EUBREAST
- trial design: prospective randomized trial to compare sentinel lymph node biopsy and observation after axillary ultrasound
- primary endpoint: distant-disease free survival
INSEMA
- PI: Toralf Reimer
- study supported by EUBREAST
- trial design: prospective randomised trial with focus to de-escalation of axillary surgery in the adjuvant setting
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Primary outcome: 5-year invasive disease-free survival (SLNB versus no SLNB in breast-conserving surgery)
Key secondary outcome: 5-year invasive disease-free survival (SLNB alone versus completion ALND in pN1a(sn) cases)
NEONOD 2
- PI: Corrado Tinterri
- study supported by EUBREAST
- trial design: multicenter non-inferiority trial to assess the effect of axillary surgery omission on the outcome of breast cancer patients presenting only micrometastasis in the sentinel lymph node after neoadjuvant chemotherapy
- primary endpoint: disease-free survival
- Study synopsis
SENOMAC
- PI: Jana de Boniface
- study supported by EUBREAST
- trial design: prospective randomized trial to compare full axillary dissection with omission of axillary dissection in patients with 1-2 positive lymph nodes (BCT and mastectomy)
- primary endpoint: breast cancer specific survival
Ongoing Trials
TAXIS
- PI: Walter P. Weber
- study supported by EUBREAST
- trial design: phase 3, prospective randomised trial to examine tailored axillary surgery with or without axillary lymph node dissection in patiens with clinically node-positive breast cancer
- primary endpoint: disease-free survival
- Study protocol
