Preoperative radiotherapy versus postoperative radiotherapy after neoadjuvant chemotherapy (“NeoRad”) in high-risk breast cancer: a prospective, randomized, international multicenter Phase III trial
ClinicalTrails.gov Unique protocol Identifier: NCT04261244
Introduction
"NeoRad" is a multicentre, prospective, international, randomised phase III trial investigating whether preoperative radiotherapy improves disease-free survival (DFS) compared to postoperative radiotherapy after neoadjuvant chemotherapy in patients with breast cancer at high risk of recurrence.
1826 patients with early-stage breast cancer and an indication for neoadjuvant chemotherapy are to be included in the study.
Primary study objective
The aim is to demonstrate the superiority of preoperative radiotherapy (PRT) of the experimental treatment plan in terms of disease-free survival (DFS) compared to the standard treatment regimen.
News
Patient recruitment has started.The first patient was registered in February 2024 and randomised in MarchThe study is open to further trial centres.
Design
Study inclusion and randomisation take place before the first evaluation of the NACT response.
More detailed information on the study design, such as inclusion and exclusion criteria, can be found in the short protocol after login.
Further information on the study:
The study is led by Prof. Dr. Christiane Matuschek, University Hospital Bielefeld (formerly Heinrich Heine University) and is being conducted by the GBG.
