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)
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Female patients aged 18-75 years.
• Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.
• 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.
Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Yiding Chen
ydchen@zju.edu.cn
+86 0571 87783759
Backup
Shijie Wu
shijiewu@zju.edu.cn
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 140
Treatments
Experimental: HIFU/Toripalimab + nab-P/Toripalimab + EC
Participants receive HIFU treatment, followed by toripalimab (Q3W) + nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by toripalimab (Q3W) + epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.
Active_comparator: nab-P/EC
Participants receive nab-Paclitaxel (QW) for 4 cycles (12 weeks), followed by epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks). Each cycle lasts 21 days.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University