NCT06964906 Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
| NCT ID | NCT06964906 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | ER+/HER2- Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-03-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged 18-75 years. 2. Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3. 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.
Contact & Investigator
Yiding Chen
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT06964906 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying ER+/HER2- Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06964906 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06964906 currently recruiting?
Yes, NCT06964906 is actively recruiting participants. Contact the research team at ydchen@zju.edu.cn for enrollment information.
Where is the NCT06964906 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06964906 clinical trial?
NCT06964906 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Yiding Chen at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 30 participants.
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