Recruiting
NeoRad Breast Cancer Study
The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT.
ClinicalTrials.gov IDNCT04261244
PhasePHASE3
Enrollment1826
SponsorBielefeld University
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT.
Interventions
- Radiation: preoperative radiotherapy — preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
- Radiation: postoperative radiotherapy — postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Primary outcomes
- disease free survival (DFS): (6 to 10 years)
Eligibility information
Inclusion Criteria:
* Histologically proven invasive, unilateral breast cancer
* Indication for radiotherapy
* Indication for neoadjuvant chemotherapy (+/- antibody treatment or other targeted therapies) in accordance with national and international guidelines
* Female
* Informed consent for the trial signed by the patient
* Hormone receptor and HER2 status: no restrictions
* All grades G1-G3
* Age ≥ 18 years at the time of informed consent
* Performance status ≤ 2
* No pre-existing conditions that prohibit therapy
Exclusion Criteria:
* Neoadjuvant treatment solely with endocrine therapy
* Bilateral breast cancer
* Pregnancy or lactation
* Prior radiotherapy of the thorax
* Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans
* Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, COPD °III)
* Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker, and/or implanted defibrillator
* Malignoma except basalioma or in-situ-carcinomas in complete response
* Distant metastasis
* Plexopathies of the arm of the treated side
* Stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident)
* Lymph edema ≥°II of the arm at the side of the breast cancer
* Other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. Expected non-compliance, etc.)
* Male patients
* Patients who have previously been assessed for chemotherapy response
Study locations
- St. Marien-Krankenhaus Ahaus, Ahaus, 48683 Germany
- Hochtaunus-Kliniken, Bad Homburg, 61352 Germany
- Sana Klinikum Lichtenberg, Berlin, 10365 Germany
- St. Agnes-Hospital, Bocholt, 46397 Germany
- Städtisches Klinikum Dessau, Dessau, 06847 Germany
- Universitätsfrauenklinik UK OWL, Klinikum Lippe, Detmold, 32756 Germany
- Universitätsklinikum Düsseldorf, Düsseldorf, 40225 Germany
- Niels-Stensen-Kliniken Franziskus-Hospital Harderberg, Georgsmarienhütte, 49124 Germany
- Sana Klinikum Hameln-Pyrmont, Hamelin, 31785 Germany
- Sana Klinikum Offenbach, Offenbach, 63069 Germany
Showing 10 of 16 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.