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RECRUITING
NCT06964906
PHASE2

Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.

Official title: A Prospective, Single-arm Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and 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

30

Start Date

2025-03-04

Completion Date

2030-12-31

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

PROCEDURE

HIFU

HIFU therapy is administered to the targeted breast lesion site.

DRUG

Toripalimab

240 mg, IV infusion, Q3W

DRUG

nab-Paclitaxel (nab-P)

125 mg/m2, IV infusion, QW

DRUG

Epirubicin (E)

90 mg/m2, IV infusion, Q3W

DRUG

Cyclophosphamide (C)

600 mg/m2, IV infusion, Q3W

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China