Trials / Recruiting
RecruitingNCT06964906
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Study participants will be randomly allocated to either the experimental group or the control group and receive the following treatments. Experimental group: HIFU therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy; Control group: 8 cycles of neoadjuvant chemotherapy alone. Each cycle lasts 21 days. Subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-03-04
- Primary completion
- 2027-12-31
- Completion
- 2030-12-31
- First posted
- 2025-05-11
- Last updated
- 2025-05-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06964906. Inclusion in this directory is not an endorsement.