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BEYOND Study: 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 (BEYOND)

2026年8月6日更新者：AstraZeneca

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

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.

研究概览

地位

招聘中

条件

乳腺癌

干预/治疗

药品：TDxd

研究类型

观察性的

注册 (估计的)

109

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Study Information Center
电话号码：+18772409479
邮箱：information.center@astrazeneca.com

学习地点

卡塔尔
- - Doha、卡塔尔
    - 尚未招聘
    - Research Site
沙特阿拉伯
- - Jeddah、沙特阿拉伯
    - 尚未招聘
    - Research Site
  - Riyadh、沙特阿拉伯
    - 尚未招聘
    - Research Site
  - Riyadh、沙特阿拉伯
    - 招聘中
    - Research Site
- Mecca Region
  - Mecca、Mecca Region、沙特阿拉伯
    - 尚未招聘
    - Research Site
阿拉伯联合酋长国
- - Abu Dhabi、阿拉伯联合酋长国
    - 尚未招聘
    - Research Site
  - Al Ain City、阿拉伯联合酋长国
    - 尚未招聘
    - Research Site
  - Dubai、阿拉伯联合酋长国
    - 尚未招聘
    - Research Site
阿曼
- - Muscat、阿曼
    - 尚未招聘
    - Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

The study population will consist of adult (age ≥ 18 years old at the date of T-DXd initiation) female patients with a confirmed diagnosis of HR-positive, HER2-low (defined as immunohistochemistry [IHC] 1+ or IHC 2+/In situ hybridization [ISH]-) or HER2-ultralow (IHC 0 with membrane staining) mBC that has progressed on one or more ET in the metastatic setting and initiated T-DXd up to 30 days before the index date.

描述

Inclusion Criteria:

-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.

Exclusion Criteria:

-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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
real-world progression-free survival 大体时间：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	18 months

次要结果测量

结果测量	措施说明	大体时间
safety profile 大体时间：18 months	To assess the safety profile (in terms of incidence and severity of adverse events [AEs], particularly treatment-emergent AEs (TEAEs) and those of special interest) and reasons for treatment discontinuation during the period with active treatment on T-DXd in the GCC countries.	18 months
baseline patient characteristics 大体时间：18 months	To assess the baseline patient characteristics and clinical presentation of patients with HR-positive, HER2-low or HER2-ultralow mBC who initiated T-DXd after progression on ET in the GCC countries.	18 months
T-DXd treatment patterns 大体时间：18 months	To describe the T-DXd treatment patterns and the lines of ET prior to T-DXd in patients with HR-positive, HER2-low or HER2-ultralow mBC in the GCC countries.	18 months
real-world time to next treatment (TTNT) 大体时间：18 months	To describe the real-world time to next treatment (TTNT) 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	18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月12日

初级完成 (估计的)

2029年3月31日

研究完成 (估计的)

2029年3月31日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年5月1日