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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)
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 ER+/HER2- breast cancer.
Official title: A Randomized, Open-Label, Blinded Endpoint 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)
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-03-04
Completion Date
2030-12-31
Last Updated
2025-05-11
Healthy Volunteers
No
Conditions
Interventions
HIFU
HIFU therapy is administered to the targeted breast lesion site.
Toripalimab
240 mg, IV infusion, Q3W
nab-Paclitaxel (nab-P)
125 mg/m2, IV infusion, QW
Epirubicin (E)
90 mg/m2, IV infusion, Q3W
Cyclophosphamide (C)
600 mg/m2, IV infusion, Q3W
Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China