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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)

NCT06964906 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yiding Chen · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964906 on ClinicalTrials.gov