NeoRad Breast Cancer Study

Last updated: May 5, 2025
Sponsor: Bielefeld University
Overall Status: Active - Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

postoperative radiotherapy

preoperative radiotherapy

Clinical Study ID

NCT04261244
NeoRad Breast Cancer Study
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven invasive, unilateral breast cancer

  • Indication for radiotherapy

  • Indication for neoadjuvant chemotherapy (+/- antibody treatment or other targetedtherapies) 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

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 thromboangiitisobliterans

  • Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onsetallergies, such as farmer's lung, severe lung emphysema, COPD °III)

  • Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heartfailure 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. Expectednon-compliance, etc.)

  • Male patients

  • Patients who have previously been assessed for chemotherapy response

Study Design

Total Participants: 1826
Treatment Group(s): 2
Primary Treatment: postoperative radiotherapy
Phase: 3
Study Start date:
February 01, 2024
Estimated Completion Date:
March 31, 2034

Study Description

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.

Connect with a study center

  • St. Marien-Krankenhaus Ahaus

    Ahaus, 48683
    Germany

    Active - Recruiting

  • Hochtaunus-Kliniken

    Bad Homburg, 61352
    Germany

    Active - Recruiting

  • Sana Klinikum Lichtenberg

    Berlin, 10365
    Germany

    Active - Recruiting

  • St. Agnes-Hospital

    Bocholt, 46397
    Germany

    Active - Recruiting

  • Städtisches Klinikum Dessau

    Dessau-Roßlau, 06847
    Germany

    Active - Recruiting

  • Universitätsfrauenklinik UK OWL, Klinikum Lippe

    Detmold, 32756
    Germany

    Active - Recruiting

  • Heinrich Heine University Hospital Duesseldorf

    Duesseldorf, 40225
    Germany

    Site Not Available

  • Tanja Fehm

    Duesseldorf, 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Duesseldorf, 40225
    Germany

    Active - Recruiting

  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

    Georgsmarienhütte, 49124
    Germany

    Active - Recruiting

  • Sana Klinikum Hameln-Pyrmont

    Hameln, 31785
    Germany

    Active - Recruiting

  • Sana Klinikum Offenbach

    Offenbach am Main, 63069
    Germany

    Active - Recruiting

  • medius Klinik Ostfildern-Ruit

    Ostfildern, 73760
    Germany

    Active - Recruiting

  • Leopoldina Krankenhaus Schweinfurt

    Schweinfurt, 97422
    Germany

    Active - Recruiting

  • Johanniter-Krankenhaus Stendal

    Stendal, 39576
    Germany

    Active - Recruiting

  • Rems-Murr-Klinikum Winnenden

    Winnenden, 71364
    Germany

    Active - Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283
    Germany

    Active - Recruiting

  • Heinrich-Braun-Klinikum

    Zwickau, 08060
    Germany

    Active - Recruiting

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