NCT04261244

NeoRad Breast Cancer Study

Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,826 (estimated)
• Sponsor: Bielefeld University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial. The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	preoperative radiotherapy	preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
RADIATION	postoperative radiotherapy	postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-03-31
• Completion: 2034-03-31
• First posted: 2020-02-07
• Last updated: 2025-05-07

Locations

16 sites across 1 country: Germany