Testing preoperative radiotherapy for breast cancer
Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial
This study is testing whether giving radiation therapy before surgery can help people with high-risk breast cancer live longer and have fewer side effects compared to the usual treatment after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1826 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Bielefeld University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 16 sites (Ahaus and 15 other locations) |
| Trial ID | NCT04261244 on ClinicalTrials.gov |
What this trial studies
The NEORAD trial investigates the effectiveness of preoperative radiotherapy compared to the standard postoperative radiotherapy in patients with high-risk breast cancer who have undergone neoadjuvant chemotherapy. This phase 3 interventional study aims to determine if administering radiotherapy before surgery can lead to improved disease-free survival and reduce late radiation effects. The trial includes patients with histologically confirmed unilateral breast cancer who meet specific eligibility criteria, ensuring a focused approach to treatment. The study is led by Prof. Dr. med. Christiane Matuschek and involves multiple clinical sites.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with histologically proven unilateral breast cancer who require neoadjuvant chemotherapy and radiotherapy.
Not a fit: Patients with bilateral breast cancer or those receiving neoadjuvant treatment solely with endocrine therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance disease-free survival rates and minimize adverse effects from radiation in breast cancer patients.
How similar studies have performed: While the optimal timing of radiotherapy in this context has not been previously addressed in randomized controlled trials, similar studies have shown promising results with preoperative treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ahaus and 15 other locations
- St. Marien-Krankenhaus Ahaus — Ahaus, Germany (Recruiting)
- Hochtaunus-Kliniken — Bad Homburg, Germany (Recruiting)
- Sana Klinikum Lichtenberg — Berlin, Germany (Recruiting)
- St. Agnes-Hospital — Bocholt, Germany (Recruiting)
- Städtisches Klinikum Dessau — Dessau, Germany (Recruiting)
- Universitätsfrauenklinik UK OWL, Klinikum Lippe — Detmold, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Niels-Stensen-Kliniken Franziskus-Hospital Harderberg — Georgsmarienhütte, Germany (Recruiting)
- Sana Klinikum Hameln-Pyrmont — Hamelin, Germany (Recruiting)
- Sana Klinikum Offenbach — Offenbach, Germany (Recruiting)
- medius Klinik Ostfildern-Ruit — Ostfildern, Germany (Recruiting)
- Leopoldina Krankenhaus Schweinfurt — Schweinfurt, Germany (Recruiting)
- Johanniter-Krankenhaus Stendal — Stendal, Germany (Recruiting)
- Rems-Murr-Klinikum Winnenden — Winnenden, Germany (Recruiting)
- Helios Universitätsklinikum Wuppertal — Wuppertal, Germany (Recruiting)
- Heinrich-Braun-Klinikum — Zwickau, Germany (Recruiting)
Study contacts
- Study coordinator: Christiane Matuschek, MD Prof.
- Email: christiane.matuschek@uni-bielefeld.de
- Phone: +495215812901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.