Actively Recruiting
Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-11
74
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 85 years
- Diagnosis of high-risk hormone receptor-positive, HER2-negative breast cancer defined by ER 61%, HER2-negative status, histologic grade II-III or high-risk genomic score
- Primary tumor size of 1.0 cm or larger with axillary lymph node-positive breast cancer
- Stage T1-4N+M0 (Stage II or III) with biopsy-confirmed lymph node positivity and no distant metastasis
- Initial PD-L1 expression on tumor tissue with Combined Positive Score (CPS) or Tumor Proportion Score (TPS) less than 10%
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Screening laboratory values meeting specified limits for white blood cells, neutrophils, platelets, hemoglobin, kidney and liver function, and coagulation
- Negative HIV screening test
- Negative or non-active Hepatitis B and C screening results after physician agreement
You will not qualify if you...
- Inflammatory breast cancer
- Life-threatening organ dysfunction, active infections, active hepatitis B or C, autoimmune diseases within past 2 years
- Current immunosuppressive drug treatment or chronic corticosteroid therapy exceeding 10 mg prednisone daily
- Clinically symptomatic heart disease
- Previous systemic treatment or radiotherapy for breast cancer
- Presence of cosmetic breast implants
- History of radiotherapy contraindications
- Currently breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jian Huang
CONTACT
T
Ting Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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