Actively Recruiting
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-11-26
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is the first to explore the clinical study of neoadjuvant radiotherapy followed by chemotherapy combined with terriplizumab in breast cancer. Participants with locally advanced (T1c-T2(≥2cm) N1-2M0 or T3-4cN0-2M0) HR-positive and HER2-negative breast cancer were enrolled to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with triplimab in the treatment of locally advanced HR-positive and HER2-negative breast cancer. About 30 participants are planned to participate in this clinical study.
CONDITIONS
Official Title
Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, any gender
- Histologically confirmed non-specific invasive ductal carcinoma, grade 3, ER ≥1%, HER2 negative, Ki-67 >20%
- Locally advanced breast cancer staged as T1c-T2 (≥2cm) N1-2 M0 or T3-4c N0-2 M0
- No prior treatment for breast cancer
- ECOG performance status 0-1
- Able to understand the study and provide informed consent
You will not qualify if you...
- Allergy to recombinant humanized anti-PD-1 monoclonal antibodies or components
- Currently enrolled in another research treatment
- Previous systemic breast cancer treatment including chemotherapy, targeted or immunotherapy
- Presence of distant metastases confirmed by imaging or pathology
- Active tuberculosis or treated for tuberculosis within the past year
- Uncontrolled or symptomatic hypercalcemia
- Clinically uncontrolled active infections
- Uncontrolled major seizures or superior vena cava syndrome
- History or current other malignant tumors except certain treated in situ cancers
- History of interstitial pneumonia or moderate to severe lung disease affecting lung function
- Known HIV infection
- Severe cardiovascular disease such as NYHA grade 2 or higher heart failure, unstable angina, arrhythmia, recent myocardial infarction or stroke
- Use of systemic immunosuppressive drugs for active autoimmune disease within 2 years
- Live virus vaccine within 4 weeks prior to study start
- Prior allogeneic stem cell or organ transplant
- Pregnant or breastfeeding women, or those not using contraception
- Any other medical or psychiatric condition that may affect study compliance or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
P
Peifen Fu, MD
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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