NCT07046195

Optimal Combination of Adjuvant Radiotherapy and Immunotherapy for Breast Cancer

Clinical Study of the Optimal Combination Mode of Adjuvant Radiotherapy Combined With Immunotherapy for Triple Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

Postoperative radiotherapy is a conventional treatment for breast cancer patients with a high risk of recurrence, such as those with regional lymph node metastasis, especially TNBC. However, the optimal mode of treatment for the combination of radiotherapy and immunotherapy has not yet been determined, especially in the adjuvant treatment phase. There is still a lack of validation and high-grade evidence on the safety and synergistic efficacy of radiotherapy-immunotherapy combinations. In this study, we aimed to compare the safety and preliminary efficacy of hypofractionated radiotherapy and concurrent immunotherapy with those of hypofractionated radiotherapy and sequential immunotherapy in the postoperative adjuvant stage through prospective real-world studies for TNBC patients, and focused on verifying the incidence of adverse reactions in radiotherapy and immunotherapy in the adjuvant stage, so as to find out the optimal combination mode of postoperative radiotherapy combined with immunotherapy, further reduce the distant metastasis of TNBC patients under the premise of ensuring safety, and improve long-term survival.

Conditions

• Hypofractionated Radiotherapy
• Triple Negative Breast Cancer (TNBC)
• Immunotherapy

Timeline

• Start date: 2024-12-11
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: China