Actively Recruiting
Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-09
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test whether a "rescue" strategy can turn chemotherapy-resistant triple-negative breast cancer (TNBC) into a curable state. Patients whose tumors fail to shrink after 2 cycles of standard neoadjuvant chemotherapy will receive a short, high-precision course of stereotactic body radiotherapy (SBRT, 24 Gy in 3 daily fractions) to the breast primary tumor, followed by 4 cycles of toripalimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel plus carboplatin. The main questions are: Can this SBRT-immuno-chemo triplet raise the pathologic complete response (pCR; no invasive cancer in breast or nodes at surgery)? Can it produce an objective radiologic response (ORR) in at least half of the patients, allowing more breast-conserving operations and fewer mastectomies? Secondary objectives include safety, changes in tumor-infiltrating lymphocytes (TILs), event-free survival, and exploratory biomarkers (whole-exome and RNA-seq, PBMC immunoprofiling) to discover signatures of benefit. Participants will undergo image-guided core biopsies before and after SBRT, provide serial blood samples, and have definitive surgery 3-5 weeks after the last cycle.
CONDITIONS
Official Title
Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 to 75 years, with newly diagnosed invasive breast cancer
- Histologically confirmed triple-negative breast cancer: ER < 1%, PR < 1%, HER2 negative
- Clinical stage II-III (tumor size T2-4 or lymph nodes N1-3, no distant metastasis)
- Completed 2 cycles of standard neoadjuvant chemotherapy with stable or progressive disease
- ECOG performance status of 0 or 1
- Radiation oncologist approval for SBRT and standard postoperative radiotherapy
- Adequate blood counts and organ function within 14 days before enrollment
- Negative for HIV, hepatitis B surface antigen, and hepatitis C antibody or viral DNA/RNA if applicable
You will not qualify if you...
- Inflammatory breast cancer
- Other cancers requiring treatment within the past 3 years except treated basal-cell skin cancer or cervical carcinoma in situ
- Active autoimmune disease, immunodeficiency, or systemic steroids over 10 mg prednisone equivalent within 2 years
- Significant heart conditions such as unstable angina, severe heart failure, or recent heart attack
- Previous radiotherapy to the breast or chest wall
- Active infections needing systemic therapy
- Known allergy or intolerance to toripalimab, paclitaxel, or carboplatin
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Department of Radiation Oncology，the Second Affiliated Hospital of Zhejiang University School of Medicine, hangzhou, zhejiang
Hangzhou, China
Actively Recruiting
Research Team
T
Ting Zhang, phD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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