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.
Study Type
OBSERVATIONAL
Enrollment
109
Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy
Research Site
Muscat, Oman
NOT_YET_RECRUITINGResearch Site
Doha, Qatar
NOT_YET_RECRUITINGResearch Site
Mecca, Mecca Region, Saudi Arabia
NOT_YET_RECRUITINGResearch Site
Jeddah, Saudi Arabia
NOT_YET_RECRUITINGResearch Site
Riyadh, Saudi Arabia
RECRUITINGResearch Site
Riyadh, Saudi Arabia
NOT_YET_RECRUITINGResearch Site
Abu Dhabi, United Arab Emirates
NOT_YET_RECRUITINGResearch Site
Al Ain City, United Arab Emirates
NOT_YET_RECRUITINGResearch Site
Dubai, United Arab Emirates
NOT_YET_RECRUITINGreal-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
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
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
Time frame: 18 months
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