A Phase II Study of T-DXd Plus Stereotactic Radiotherapy(SRT) in HER2-positive Breast Cancer Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Intracranial objective response rate(IC-ORR)
研究概览
简要总结
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing 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 advanced breast cancer
- •Age>18 years.
- •Brain metastases confirmed by enhanced brain MRI. Metastases number less than
- •KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM
- •Life expectancy of more than 6 months
- •Prior therapy of oral dexamethasone not exceeding 16mg/d
- •Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade
- •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)
- •QTcF < 480 ms
- •INR≤1.5×ULN，APTT≤1.5×ULN
- •Signed the informed consent form prior to patient entry
排除标准
- •Leptomeningeal or hemorrhagic metastases
- •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
Combination use of SRT with T-DXd
Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced.
Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg
干预措施: Combination use of SRT with T-DXd (Drug)
结局指标
主要结局
Intracranial objective response rate(IC-ORR)
时间窗: 2 years
Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors as defined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria.
次要结局
- Overall survival(OS)(3 years)
- Percentage of Participants With Adverse Events Percentage of Participants With Adverse Events(2 years)
- Progression Free Survival(PFS)(2 years)
- Local control rate(2 years)
- Health-related quality of life per FACT-BR(2 years)
- Neurocognitive function per HVLT-R(2 years)
- Intracranial CNS Progression Free Survival(IC-PFS)(2 years)
研究者
Xiaoli Yu
Clinical Professor
Fudan University