NCT07597993招募中不适用
A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns and Outcomes of Trastuzumab Deruxtecan in Patients With HR Positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated With Endocrine Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 109
- 试验地点
- 11
- 主要终点
- real-world progression-free survival
研究概览
简要总结
BEYOND study is designed to generate the first real-world data from GCC countries on the patient characteristics, treatment patterns, survival outcomes, and safety of T-DXd in patients with HRpositive,HER2-low or HER2-ultralow mBC previously treated with ET. The evidence generated will help to optimise treatment strategies, inform clinical guidelines, and ultimately improve outcomes for patients with mBC across the region.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 old at the time of T-DXd initiation
- •Patients with a confirmed histological or cytologically based diagnosis of HR-positive mBC.
- •Patients who were classified as HER2-low or HER2-ultralow mBC confirmed by the closest locally obtained HER2 test prior to or on the index date, and who meet the following definitions:
- •HER2-low status defined as IHC scores 1+ and 2+ without ISH gene amplification based on the pathology report.
- •HER2-ultralow status defined as IHC 0 with membrane staining based on the pathology report.
- •Patient who received at least one prior line of ET (± targeted therapy) in the metastatic setting.
- •Patients who are chemotherapy-naïve in the metastatic setting.
- •Patients who initiated T-DXd up to 30 days before the signature of the ICF. The decision to initiate T-DXd must be made independently by treating physicians as part of routine clinical practice.
- •Patients are willing to sign the written ICF, indicating that they understand the purpose of the study and procedures required for participation.
排除标准
- •-Patients with a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
- •Patients who received prior chemotherapy in the metastatic setting.
- •Patients with Eastern Cooperative Oncology Group (ECOG) status ≥2 or missing ECOG status at the time of initiation of T-DXd (index date).
- •Patients with a history of participation in another clinical trial in the metastatic setting.
- •Female patient with current or planned pregnancy, or breastfeeding.
结局指标
主要结局
real-world progression-free survival
时间窗: 18 months
To describe the real-world progression-free survival (rwPFS) of T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries
次要结局
- safety profile(18 months)
- baseline patient characteristics(18 months)
- T-DXd treatment patterns(18 months)
- real-world time to next treatment (TTNT)(18 months)
研究者
研究点 (11)
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