Trials
Completed Trials
1. SOUND: Sentinel node vs Observation after axillary Ultra-souND
- PI: Oreste Gentilini
- trial design: prospective randomized trial to compare sentinel lymph node biopsy and observation after axillary ultrasound
- primary endpoint: distant-disease free survival
>> Link
2. INSEMA
- PI: Toralf Reimer
- trial design: prospective randomised trial, xxx
- primary endpoint: xxx
>> Link
Ongoing Trials
EUBREAST has developed several new study protocols that address important scientific questions to improve breast cancer surgery. These studies are listed below.
EUBREAST supports the following ongoing trials:
1. SENOMAC
- PI: Jana de Boniface
- 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
>> Link
2. TAXIS
- PI: Walter P. Weber
- 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
>> Link
>> Link
3. AGO 35 (Accrual completed)
- PI: Florentia Peintinger
- 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.
>> Link
4. TATTOO-Study: Tattooing suspicious axillary lymph nodes in breast cancer patients treated by primary systemic therapy (Accrual completed)
- PI: Steffi Hartmann (MD)
- 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.
>> Link
Future Trial Projects
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
- trial design: prospective, multi-center, single-arm
- primary endpoint: 3-year ipsilateral axillary recurrence rate
>> Link
2. INDAX / EUBREAST 2
- PI: Jana de Boniface
- trial design: International multi‐centre phase III randomised clinical trial with non‐inferiority endpoint.
- primary endpoint: Invasive Disease‐Free Survival (iDFS)
>> Link
3. AXSANA / EUBREAST 3
- PI: Thorsten Kühn
- trial design: European prospective multicenter registry on axillary surgical techniques after neoadjuvant chemotherapy.
- primary endpoint: Invasive Disease‐Free Survival (iDFS)
>> Link