Testing preoperative radiotherapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

Study contacts

• Study coordinator: Christiane Matuschek, MD Prof.
• Email: christiane.matuschek@uni-bielefeld.de
• Phone: +495215812901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.