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)
NCT ID: NCT06964906
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2025-03-04
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
HIFU
HIFU therapy is administered to the targeted breast lesion site.
Toripalimab
240 mg, IV infusion, Q3W
nab-Paclitaxel (nab-P)
125 mg/m2, IV infusion, QW
Epirubicin (E)
90 mg/m2, IV infusion, Q3W
Cyclophosphamide (C)
600 mg/m2, IV infusion, Q3W
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.
nab-Paclitaxel (nab-P)
125 mg/m2, IV infusion, QW
Epirubicin (E)
90 mg/m2, IV infusion, Q3W
Cyclophosphamide (C)
600 mg/m2, IV infusion, Q3W
Interventions
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HIFU
HIFU therapy is administered to the targeted breast lesion site.
Toripalimab
240 mg, IV infusion, Q3W
nab-Paclitaxel (nab-P)
125 mg/m2, IV infusion, QW
Epirubicin (E)
90 mg/m2, IV infusion, Q3W
Cyclophosphamide (C)
600 mg/m2, IV infusion, Q3W
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yiding Chen
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-0367
Identifier Type: -
Identifier Source: org_study_id
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