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

2022 virtual OPBC consensus conference on uncertainties and controviersies in axillary management of patients with breast cancer

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 PROGRAM

Online 3 April 2023
Title: Interdisciplinary Management of Breast Cancer Patients Treated with Primary Systemic Therapy: What Surgeons Need to Know
Brief Description: Five CME-accredited Educational Modules Online
Moderators: Thorsten Kuehn and Oreste Gentilini
Guest Speakers: Giuseppe Curigliano, Oreste Gentilini, Orit Kaidar-Person, Petra Steyerova, Giuseppe Viale

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

EUBREAST 14 (R) OPBC05 - EUBREAST 14 ICARO Study

Leading PIs: Giacomo Montagna, Walter Weber
EUBREAST PIs: Thorsten Kuehn, Oreste Gentilini
Study Supported by EUBREAST
Trial Design: Multicenter retrospective cohort study
Brief Description: Nodal burden and nodal recurrence in patients with isolated tumor cells after neoadjuvant chemotherapy treated with axillary dissection or nodal radiation
Primary Endpoints:
- Patterns of treatment (TAD/SLNB +/- ALND +/- axillary RT) by geographic region and over time
- Incidence of additional micro and macrometastases removed by ALND
- 3-year rate of axillary recurrence
Protocol
Synopsis

EUBREAST 15 (R) GraMaReg (GRAnulomatous MAstitis REGistry Study)

PIs: Natalia Krawczyk and Maggie Banys-Paluchowski
Study initiated by EUBREAST
Trial design: Non-interventional registry study / cohort study to evaluate risk factors, clinical courses and therapeutic strategies in patients with granulomatous mastitis
Primary efficacy endpoints:
- Clinical symptoms (pain, redness, palpable mass)
- Type and duration of the medical treatment
- Number of surgeries, if performed
- Clinical outcome: duration of symptoms and recurrence rate

EUBREAST 16 (R) – Neo-ACT Trial

Description

The Neo-ACT trial is a randomized study to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer.

For more information, please see the Neo-ACT website: https://ki.se/en/mmk/the-neo-act-trial

Documents

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
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

Additional projects EUBREAST has promoted

Breast cancer treatment in the COVID 19 pandemic EUBREAST offers access to relevant literature and recommendations for physicians and patients.

EUBREAST would like to share the message of the European Cancer Organisation’s Time to Act campaign -
Don’t let Covid-19 stop you from tackling Cancer https://www.europeancancer.org/timetoact

EUBREAST supports the PER.D.I.T.A survey from i BRA-NET, please share this link with colleagues and friends
Link to the study