An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Females ≥18 yrs old;
- •Pathologically confirmed HER2-positive advanced breast cancer;
- •At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- •Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- •Life expectancy is not less than 6 months.
- •Adequate function of major organs.
排除标准
- •Subjects with leptomeningeal metastasis
- •CNS complications requiring emergency neurosurgical intervention
- •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;
- •Suffering from heart disease that is not well controlled or having clinical symptoms
- •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.
- •Female subjects during pregnancy and lactation
- •Any other conditions that researchers believe that patients are unsuitable for this study.
研究组 & 干预措施
control group
Trastuzumab Rezetecan
干预措施: Trastuzumab Rezetecan (Drug)
experimental group
Trastuzumab Rezetecan combined with radiotherapy
干预措施: Trastuzumab Rezetecan (Drug)
experimental group
Trastuzumab Rezetecan combined with radiotherapy
干预措施: FSRT or WBRT (Radiation)
结局指标
主要结局
PFS
时间窗: up to 1.5 years
次要结局
- CNS-ORR(2 months)
- ORR by investigator using RECIST Guideline(2 months)
- CNS-PFS(1.5 year)
- Adverse events(up to 1.5 years)
研究者
Min Yan, MD
Chief Physician
Henan Cancer Hospital