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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

-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.

Disqualifiers

-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.

Trial design

Treatments tested in this trial

  • TDxd

Treatment groups

No treatment groups listed

Sponsors and collaborators