Phase 2 Study of Toripalimab with Stereotactic Body Radiotherapy and Chemotherapy for Women with Chemotherapy-Resistant Triple-Negative Breast Cancer

What this Trial Is About

Researchers are studying a new treatment approach for women with early-stage triple-negative breast cancer TNBC who do not respond to standard chemotherapy. The goal is to see if adding a precise form of radiation therapy called stereotactic body radiotherapy SBRT followed by a combination of immunotherapy and chemotherapy can improve the chances of completely eliminating invasive cancer before surgery. This phase II trial focuses on patients whose tumors remain stable or progress after two cycles of chemotherapy and looks at cancer response, safety, and immune changes. Participants will first receive SBRT to the breast tumor in three daily doses totaling 24 Gy. The day after completing SBRT, they start immunotherapy with toripalimab given intravenously every 21 days for 4 cycles. Along with toripalimab, patients receive chemotherapy using albumin-bound paclitaxel and carboplatin on a 21-day cycle, for four cycles. Surgery to remove the tumor is scheduled 3 to 5 weeks after finishing the treatment cycles, followed by standard post-operative radiation therapy without an extra boost to the original tumor site. Throughout the study, patients will have image-guided biopsies before and after SBRT, blood samples taken regularly, and detailed assessments including tumor response by imaging, immune cell changes in the tumor, and safety monitoring of side effects. The main outcome measured is the complete absence of invasive cancer at surgery. Secondary outcomes include tumor shrinkage seen on scans, side effects, event-free survival, and potential biomarkers that may predict treatment benefit. Participation lasts through surgery and post-treatment follow-up.

Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer