Actively Recruiting
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
Led by Xijing Hospital · Updated on 2025-07-15
27
Participants Needed
2
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.
CONDITIONS
Official Title
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years at the time of signing informed consent
- ECOG performance status of 0 or 1
- Non-metastatic breast cancer (M0) at clinical stage IIB, IIIA, IIIB, or IIIC
- Required imaging assessments within 28 days before enrollment: abdominal CT, bone scan, chest CT, and brain MRI
- Histologically or pathologically confirmed invasive carcinoma of no special type with grade 2 or 3
- Estrogen receptor-positive (>1% staining) and/or progesterone receptor-positive (>1% staining) by immunohistochemistry
- HER2-negative status confirmed by IHC 0/1+ or FISH ratio ≤1.8
- Ki-67 proliferation index ≥15%
- Eligible for radiotherapy after multidisciplinary team evaluation
- No prior antitumor therapy within 1 month before enrollment
- Adequate organ function within 7 days before enrollment, including blood counts, liver and kidney function, coagulation, urinalysis, and thyroid function
- Negative pregnancy test within 7 days before treatment for women of childbearing potential
- Use of highly effective contraception during the study and for 180 days after the last dose
- Voluntary informed consent and commitment to follow-up
You will not qualify if you...
- Inflammatory breast cancer
- Known or suspected autoimmune diseases, except treated hypothyroidism or stable type-1 diabetes
- Poorly controlled hypertension or recent serious cardiovascular events within 6 months
- Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases
- Receipt of live attenuated vaccines within 28 days before enrollment or planned during study
- Active infections including HIV/AIDS, hepatitis with high viral loads, recent severe infections, or active tuberculosis
- Unexplained fever over 38.5°C during screening unless tumor-related
- Other malignancies diagnosed within 5 years except certain adequately treated skin or cervical cancers
- Major surgery within 28 days prior to enrollment (biopsies or PICC line allowed)
- Prior or planned organ or bone marrow transplant
- Peripheral neuropathy grade 2 or higher
- Clinically significant bowel obstruction
- Recent arterial or venous thrombosis within 6 months
- Significant bleeding risks or known bleeding/thrombotic disorders
- Coagulation abnormalities or requirement for long-term anticoagulation or high-dose antiplatelet therapy
- Prior systemic targeted therapy or immunostimulants within 4 weeks before treatment
- Known allergy to the investigational drug or its components
- Participation in another drug trial within 4 weeks or within 5 half-lives of last investigational drug
- History of drug or alcohol abuse
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other conditions that may affect safety or study integrity as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi Province, China, 710032
Actively Recruiting
2
Xijing Hospital Affiliated to Air Force Military Medical University
Xi'an, Shannxi, China
Actively Recruiting
Research Team
J
JIAJUN DING
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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