Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer

• Status: RECRUITING
• Trial end date: 2027-11-01

Summary

The goal of this clinical trial is to compare the efficacy and safety in patients with lymph node-positive HR+/HER2- breast cancer. The main questions it aims to answer are:

• Can the incorporation of intensified radiation to the tumor (tumor boost) enhance the pCR rate on the basis of neoadjuvant immuno-chemotherapy
• Can it improve the level of residual cancer burden (RCB) and change the tumor immune microenvironment? and How safe will be the combined therapy?

Participants will be randomly assigned to one of three treatment regimens:

1. Preoperative toripalimab combined with SBRT targeting both the primary tumor and axillary lymph nodes, followed by chemotherapy;

2. Preoperative toripalimab combined with SBRT focused solely on the primary tumor, followed by chemotherapy;

3. Preoperative toripalimab combined with chemotherapy alone.

Following the completion of their respective treatment regimens, participants will proceed to undergo surgery. The effectiveness of the treatments will be assessed through pathological evaluations, as well as by measuring levels of residual cancer burden (RCB) and examining changes in the tumor immune microenvironment.

The study aims to evaluate the safety of these combined treatment approaches and to determine if they offer superior efficacy compared to outcomes reported in previous studies.

• Phase: PHASE2

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University