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

Recruiting now · Phase 2

Conditions studied: ER+/HER2- Breast Cancer

In brief

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.

Key facts

Study ID

NCT06964906

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

30

Starts

2025-03-04

Expected to finish

2030-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged 18-75 years.
• Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3.
• 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.

You may not qualify if…

• 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.

Where it is running

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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