NeoRad Breast Cancer 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

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

Conditions2

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