Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1826 participants
INTERVENTIONAL
2024-02-01
2034-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm
preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
preoperative radiotherapy
preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Standard treatment
standard treatment (postoperative radiotherapy) in breast cancer after neoadjuvant chemotherapy
postoperative radiotherapy
postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Interventions
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preoperative radiotherapy
preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
postoperative radiotherapy
postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Bielefeld University
OTHER
Responsible Party
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Principal Investigators
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Christiane M Prof., MD Prof.
Role: STUDY_CHAIR
Bielefeld University
Locations
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St. Marien-Krankenhaus Ahaus
Ahaus, , Germany
Hochtaunus-Kliniken
Bad Homburg, , Germany
Sana Klinikum Lichtenberg
Berlin, , Germany
St. Agnes-Hospital
Bocholt, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
Universitätsfrauenklinik UK OWL, Klinikum Lippe
Detmold, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Georgsmarienhütte, , Germany
Sana Klinikum Hameln-Pyrmont
Hamelin, , Germany
Sana Klinikum Offenbach
Offenbach, , Germany
medius Klinik Ostfildern-Ruit
Ostfildern, , Germany
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, , Germany
Johanniter-Krankenhaus Stendal
Stendal, , Germany
Rems-Murr-Klinikum Winnenden
Winnenden, , Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, , Germany
Heinrich-Braun-Klinikum
Zwickau, , Germany
Countries
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Central Contacts
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Facility Contacts
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Hermann Voß, Dr. med.
Role: primary
Other Identifiers
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NeoRad Breast Cancer Study
Identifier Type: -
Identifier Source: org_study_id
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