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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TDxd
  Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy

Первичные конечные точки

• real-world progression-free survival [Срок оценки: 18 months]

Вторичные конечные точки (4)

• safety profile [Срок оценки: 18 months]
• baseline patient characteristics [Срок оценки: 18 months]
• T-DXd treatment patterns [Срок оценки: 18 months]
• real-world time to next treatment (TTNT) [Срок оценки: 18 months]

Критерии участия

Критерии включения

• -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.

Критерии исключения

• -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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

ОАЭ · 2 центра

• Research Site — Abu Dhabi
• Research Site — Al Ain City

Идентификаторы

NCT: NCT07597993 · D7814R00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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