NCT06975462尚未招募2 期
SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases: a Prospective，Sigle-arm，Phase II Study
Wuhan Union Hospital, China0 个研究点目标入组 30 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The objective response rate of intracranial（IC-ORR）
研究概览
简要总结
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
- •Age>18 years.
- •newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than
- •No more than four lines of previous advanced therapy
- •Life expectancy of more than 3 months
- •There were no known or suspected leptomeningeal brain metastases
- •The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
- •The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, but the dose was stable for at least a week without the need for an increment
- •Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
- •Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) LVEF ≥ 50% QTcF < 480 ms INR≤1.5×ULN，APTT≤1.5×ULN 10.Signed the informed consent form prior to patient entry
排除标准
- •Leptomeningeal or hemorrhagic metastases
- •previously used T-dxd
- •Uncontrolled epilepsy
- •Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
- •History of allergy to treatment regimens
- •Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
- •Inability to complete enhanced MRI
- •Not suitable for inclusion for specific reasons judged by sponsor -
研究组 & 干预措施
SHR-A1811+radiotherapy
Experimental
SHR-A1811:4.8mg/kg radiotherapy:800cGY*5
干预措施: SHR-A1811 and radiotherapy (Combination Product)
结局指标
主要结局
The objective response rate of intracranial（IC-ORR）
时间窗: 2 years
Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors
次要结局
- Intracranial CNS Progression Free Survival(IC-PFS)(2 years)
- Progression Free Survival(PFS)(2 years)
- Adverse Events(2 years)
- Overall survival(OS)(3 years)
研究者
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