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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TDxd.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug TDxd
Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy
Primary outcome measures
- real-world progression-free survival [Time frame: 18 months]
Secondary outcome measures (4)
- safety profile [Time frame: 18 months]
- baseline patient characteristics [Time frame: 18 months]
- T-DXd treatment patterns [Time frame: 18 months]
- real-world time to next treatment (TTNT) [Time frame: 18 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Arab Emirates · 2 centers
- Research Site — Abu Dhabi
- Research Site — Al Ain City
Identifiers
NCT: NCT07597993 · D7814R00001