Status:
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)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
ER+/HER2- Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Study participants will be randomly allocated to either the experimental group or the control group and receive the following treatments. Experimental group: HIFU therapy followed by 8 cycles of neoad...
Eligibility Criteria
Inclusion
- 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 ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion
- Female patients during pregnancy or lactation.
- Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
- Has an active autoimmune disease that has received systemic treatment in the last 2 years.
- Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
- Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06964906
Start Date
March 4 2025
End Date
December 31 2030
Last Update
May 11 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000