NeoRad Breast Cancer Study
Recruiting · NCT04261244 · Interventional (participants receive a specific treatment) · Lead sponsor: Bielefeld University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
16 locations listed.
- 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