Trials
Completed Trials
1. 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.
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
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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)
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
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.
