Study of Efficacy and Toxicity of Trastuzumab Deruxtecan in Metastatic HER2-Positive Breast Cancer Patients: Single Center Experience, Madinah, Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
A single-center observational study (retrospective + prospective) evaluating the real-world efficacy and toxicity profile of Trastuzumab Deruxtecan (T-DXd) in adult female patients with HER2-positive metastatic breast cancer treated at KSAMC, Madinah, Saudi Arabia
详细描述
Includes patient demographics, treatment lines (2nd line or beyond), dosing schedule, response assessment per RECIST 1.1, and adverse event grading per CTCAE v5.0
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Female patients aged ≥ 18 years
- •Histologically confirmed HER2-positive metastatic breast cancer
- •Progression during or within 6 months of finishing adjuvant anti-HER2 therapy (T-DXd as 2nd line), OR de novo metastatic disease previously treated with ≥ 2 lines of anti-HER2 therapy (T-DXd as 3rd line or beyond)
- •ECOG Performance Status 0-1
- •LVEF ≥ 50% on echocardiography
- •Measurable lesions per RECIST v1.1
- •Adequate hematologic, hepatic, and renal function
排除标准
- •History of non-infectious interstitial lung disease (ILD) / pneumonitis requiring steroids
- •Active uncontrolled infection
- •Symptomatic/uncontrolled brain metastases
- •Severe cardiac dysfunction (LVEF < 50%)
- •Pregnancy or lactation
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: 2 years
proportion of patients achieving CR + PR + SD per RECIST 1.1
PFS
时间窗: 2 years
time from treatment initiation to progression or death
OS
时间窗: 2 years
time from treatment initiation to death from any cause
次要结局
- Toxcicity(2 years)
研究者
Mohamed Ali Elbaiomy
Prof. Mohamed Ali Elbaiomy, Medical Oncology Consultant
Mansoura University