Recruiting

NeoRadPreoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial

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What is being tested

preoperative radiotherapy

+ postoperative radiotherapy

Radiation
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorBielefeld University
Study ContactChristiane Matuschek, MD Prof.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2024

Actual date on which the first participant was enrolled.

The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial. The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.

Official TitlePreoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial
NCT04261244
Principal SponsorBielefeld University
Study ContactChristiane Matuschek, MD Prof.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1826 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

10 inclusion criteria required to participate
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
Show More Criteria
15 exclusion criteria prevent from participating
Plexopathies of the arm of the treated side
Neoadjuvant treatment solely with endocrine therapy
Bilateral breast cancer
Pregnancy or lactation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Group II

Active Comparator
standard treatment (postoperative radiotherapy) in breast cancer after neoadjuvant chemotherapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Recruiting

St. Marien-Krankenhaus Ahaus

Ahaus, GermanyOpen St. Marien-Krankenhaus Ahaus in Google Maps
Recruiting

Hochtaunus-Kliniken

Bad Homburg, Germany
Recruiting

Sana Klinikum Lichtenberg

Berlin, Germany
Recruiting

St. Agnes-Hospital

Bocholt, Germany
Recruiting
16 Study Centers