Actively Recruiting
Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy in High-risk Breast Cancer A Prospective, Randomized, International Multicenter Phase III Trial
Led by Bielefeld University · Updated on 2025-05-07
1826
Participants Needed
16
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best timing for radiotherapy in women with high-risk breast cancer who have received neoadjuvant chemotherapy. The study compares preoperative radiotherapy to the standard postoperative radiotherapy to see if it improves disease-free survival and reduces radiation-related late side effects. This is a randomized phase III trial conducted internationally to address an important gap in breast cancer treatment. Participants are randomly assigned to receive either radiotherapy before surgery or the usual radiotherapy after surgery. Both treatments include radiation to the whole breast or chest wall, with additional boosts to the tumor bed when breast-conserving surgery is performed. If lymph nodes are involved, radiation to regional lymph nodes is also given. Treatments follow national and international guidelines and are carefully monitored. Throughout the study, participants will be followed for 6 to 10 years to assess disease-free survival as the main outcome. Researchers will also track local and regional recurrences, metastasis-free survival, overall and disease-specific survival, cosmetic results, quality of life, arm lymphedema, brachial plexus toxicity, and other treatment-related side effects. Regular evaluations by physicians and patient questionnaires will help monitor safety and effectiveness over the long term.
CONDITIONS
Brief Title
NeoRad Breast Cancer Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven invasive, unilateral breast cancer
- Indication for radiotherapy
- Indication for neoadjuvant chemotherapy with or without antibody or targeted therapies
- Female sex
- Signed informed consent
- Hormone receptor and HER2 status: no restrictions
- All tumor grades G1 to G3
- Age 18 years or older at consent
- Performance status 2 or less
- No pre-existing conditions prohibiting therapy
You will not qualify if you...
- Neoadjuvant treatment only with endocrine therapy
- Bilateral breast cancer
- Pregnancy or lactation
- Prior radiotherapy of the chest area
- Connective tissue diseases like rheumatoid arthritis or thromboangiitis obliterans
- Symptomatic chronic lung diseases such as fibrosis, pneumoconiosis, severe emphysema, COPD stage III
- Heart conditions including symptomatic coronary disease, heart attack history, heart failure NYHA II or higher, pacemaker or defibrillator
- Other cancers except basal cell carcinoma or fully resolved in-situ carcinomas
- Distant metastases
- Plexopathies or stiffness in the shoulder or arm on the treated side
- Lymphedema grade II or higher on the affected arm
- Medical conditions preventing neoadjuvant radiotherapy including expected non-compliance
- Male patients
- Prior assessment for chemotherapy response before enrollment
Research Team
C
Christiane Matuschek, MD Prof.
D
Deborah Wöstenfeld, M. A.
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