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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-75 years.
- •Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: nab-Paclitaxel (nab-P) (Drug)
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.
干预措施: Toripalimab (Drug)
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.
干预措施: Epirubicin (E) (Drug)
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.
干预措施: Cyclophosphamide (C) (Drug)
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.
干预措施: HIFU (Procedure)
结局指标
主要结局
Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
时间窗: Up to approximately 30 weeks
The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.
次要结局
- Event-Free Survival (EFS)(Approximately five years)
- Adverse Event (AE)(Approximately three years)
- Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis(Up to approximately 30 weeks)
- Objective Response Rate (ORR)(Up to approximately 30 weeks)