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.
-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.
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.
-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.
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.
Case-only
Prospective
TDxd
DrugObserving Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy
real-world progression-free survival
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
safety profile
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.
baseline patient characteristics
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.
T-DXd treatment patterns
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.
real-world time to next treatment (TTNT)
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
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