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.

2. 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.

3. 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

4. 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)

Ongoing Trials

EUBREAST has developed several new study protocols that address important scientific questions to improve breast cancer surgery. These studies are listed below.

1. EUBREAST 1: 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

2. AXSANA / EUBREAST 3

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

3. 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

4. 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

5. 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

6. OPBC-04/EUBREAST-06 OMA

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
Study Protocol

Future Trial Projects

1. INDAX / EUBREAST 2 

PI: Jana de Boniface 
study initiated by EUBREAST
trial design: International multi‐centre phase III randomised clinical trial with non‐inferiority endpoint.
primary endpoint: Invasive Disease‐Free Survival (iDFS)

2. MELODY / EUBREAST 4

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

3. SERMA (Seroma of the Mammary gland) / EUBREAST 5

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.