Actively Recruiting
Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-05-11
140
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
CONDITIONS
Official Title
Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-75 years
- Invasive breast cancer without distant metastasis, including either T1c-T2 ( 2 cm), cN1-cN2, or T3-T4, cN0-cN2
- Histopathologically confirmed estrogen receptor-positive/HER2-negative breast cancer with PR < 20% or Ki67 20%, Grade 3
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
You will not qualify if you...
- Female patients who are pregnant or lactating
- Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology
- Active autoimmune disease treated systemically in the last 2 years
- Known history of HIV, hepatitis B, or active hepatitis C infection
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- History of invasive malignancy requiring systemic treatment in the last 5 years
- Uncontrolled severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, or other diseases requiring systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yiding Chen
CONTACT
S
Shijie Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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