RecruitingPhase 2NCT06964906

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)

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)


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

140 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding HIFU (a focused ultrasound treatment that uses heat to target tumors) along with an immunotherapy drug (toripalimab) to standard chemotherapy works better than chemotherapy alone before surgery for a certain type of hormone-positive, HER2-negative breast cancer. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have invasive breast cancer that hasn't spread to distant organs - Your tumor is hormone receptor-positive and HER2-negative, with specific features (low progesterone receptor expression or high cell growth rate or grade 3) - Your tumor is larger than 2 cm or you have lymph node involvement - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have cancer in both breasts or cancer that has spread to distant organs - You have significant immune system or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHIFU

HIFU therapy is administered to the targeted breast lesion site.

DRUGToripalimab

240 mg, IV infusion, Q3W

DRUGnab-Paclitaxel (nab-P)

125 mg/m2, IV infusion, QW

DRUGEpirubicin (E)

90 mg/m2, IV infusion, Q3W

DRUGCyclophosphamide (C)

600 mg/m2, IV infusion, Q3W


Locations(1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06964906


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