NCT06361979尚未招募2 期
A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
Huihua Xiong0 个研究点目标入组 30 人开始时间: 2024年5月最近更新:
适应症
干预措施
相关药物
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
- CNS-ORR
研究概览
简要总结
This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old;
- •Pathologically confirmed HER2-positive breast cancer;
- •At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- •More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed.
- •Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
- •Adequate function of major organs-
排除标准
- •Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
- •Previous treatment with bevacizumab;
- •Participated in other drug clinical trials within 4 weeks before admission;
- •History of clinically significant lung disease；
- •Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- •According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- •Any other conditions that researchers believe that patients are unsuitable for this study.
研究组 & 干预措施
ARM1
Experimental
干预措施: SHR-A1811 (Drug)
ARM1
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
CNS-ORR
时间窗: Up to 2 years
CNS-ORR was defined as percentage of participants with CNS response assessed by the investigator according to RANO-BM criteria
次要结局
- PFS(up to 2 years)
- ORR(Up to 2 years)
- AE(Up to 2 years)
研究者
Huihua Xiong
Professor
Tongji Hospital
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