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)

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · May 7, 2025

Keywords

ClinConnect Summary

The NeoHunter clinical trial is studying a new treatment approach for women with a specific type of breast cancer known as estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-). This trial is comparing the effects of high-intensity focused ultrasound (HIFU) combined with a medication called toripalimab and chemotherapy against standard chemotherapy alone. The main goal is to see if this new combination can help shrink the tumors before surgery and improve overall treatment outcomes.

To participate in this study, women aged 18 to 75 who have been diagnosed with invasive ER+/HER2- breast cancer may be eligible, provided their cancer meets certain conditions. For instance, their tumors should be a specific size or stage, and they should not have other serious health issues or conditions like active autoimmune diseases. If chosen to participate, women will receive the study treatments and be closely monitored for their safety and how well the treatment works. This trial is currently recruiting participants, and it could be an opportunity for those looking for new treatment options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female patients aged 18-75 years.
• • 2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.
• • 3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Exclusion Criteria:
• • 1. Female patients during pregnancy or lactation.
• • 2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
• • 3. Has an active autoimmune disease that has received systemic treatment in the last 2 years.
• • 4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
• • 5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• • 6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
• • 7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.