NCT07616440招募中不适用
Pilot Study on the Clinical Efficacy of Focused Ultrasound-Mediated Targeted Drug Delivery System Combined With Neoadjuvant Therapy for HER2-Positive Breast Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tumor Pathological Complete Response
研究概览
简要总结
This study aimed to evaluate the feasibility and safety, and to observe early efficacy signals of the focused ultrasound mediated drug delivery system combined with SonoVue® in patients with HER2-positive breast cancer receiving neoadjuvant therapy by comparing its pathological complete response (pCR) rate with a matched historical cohort of HER2-positive breast cancer patients treated at our center.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years.
- •Histologically confirmed HER2 positive breast cancer, with indication for neoadjuvant chemotherapy, and scheduled to receive the T(P)CbHP neoadjuvant regimen.
- •TNM stage T2N0-2M
- •Adequate bone marrow reserve (ANC >1.5×10⁹/L, platelets >100×10⁹/L).
- •Normal liver function (ALAT, ASAT, and bilirubin <2.5× upper limit of normal).
- •Adequate renal function (creatinine clearance >50 mL/min).
- •Left ventricular ejection fraction (LVEF) ≥50% measured by echocardiography or MUGA.
- •No psychological, family, social, or geographical conditions that would compromise compliance with the study protocol and follow-up schedule.
- •No medical conditions that would place the subject at undue risk.
- •Written informed consent signed by the subject.
排除标准
- •Prior history of radiotherapy or chemotherapy.
- •Pregnant or lactating patients.
- •Presence of distant metastasis.
- •Bilateral invasive breast cancer.
- •Concurrent administration of other anticancer therapies or another investigational agent.
- •inadequate physical tolerance, including significant cardiovascular, hepatic, or renal dysfunction, massive ascites, intestinal obstruction, severe infection, high fever, as well as water-electrolyte and acid-base imbalance.
- •Patients with known hyper sensitivity to SonoVue®.
研究组 & 干预措施
Focused Ultrasound Combined with Neoadjuvant Therapy
Experimental
干预措施: Focused Ultrasound-Mediated Targeted Drug Delivery Combined with Neoadjuvant Therapy (Device)
结局指标
主要结局
Tumor Pathological Complete Response
时间窗: 18 weeks from the enllorment, after the surgey
Pathological Complete Response rate
时间窗: 18 weeks from the enrollment, after the surgey
次要结局
- Event-Free Survival (EFS)(3 years after the surgery)
研究者
研究点 (1)
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