Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIFU, Toripalimab, nab-Paclitaxel (nab-P), Epirubicin (E).
- Who it may be relevant to
- Registry conditions: ER+/HER2- Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-arm Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)
Overview
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.
Detailed description
Study participants will receive the following treatments: HIFU therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy. Each cycle lasts 21 days. Subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.
Interventions
- 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
Primary outcome measures
- Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0 [Time frame: Up to approximately 30 weeks]
Secondary outcome measures (4)
- Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis [Time frame: Up to approximately 30 weeks]
- Objective Response Rate (ORR) [Time frame: Up to approximately 30 weeks]
- Event-Free Survival (EFS) [Time frame: Approximately five years]
- Adverse Event (AE) [Time frame: Approximately three years]
Eligibility criteria
Inclusion criteria
- Female patients aged 18-75 years.
- Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3.
- 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.
Exclusion criteria
- Female patients during pregnancy or lactation.
- Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
- Has an active autoimmune disease that has received systemic treatment in the last 2 years.
- Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
- Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT06964906 · 2024-0367