BEYOND Study: A Multicentre, Prospective, Observational Study of Real-world Treatment Patterns an… (NCT07597993) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
United Arab Emirates109 participantsStarted 2026-06-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is described as an observational study, not a randomized trial — does that mean I would receive trastuzumab deruxtecan as part of my regular treatment plan rather than being randomly assigned to it, and how does that affect what I can expect from participating?
2Since this study focuses on patients with HR-positive, HER2-low or HER2-ultra-low metastatic breast cancer who have already had endocrine therapy, does my treatment history and HER2 status actually fit the profile this study is looking at?
3The trial is listed as 'not yet recruiting' — how far away might it be from opening, and should I be considering other treatment options or trials in the meantime rather than waiting for this one?
4The main thing this study is tracking is real-world progression-free survival, meaning how long patients go without their cancer worsening outside a controlled trial setting — does the existing clinical trial data on trastuzumab deruxtecan already give us enough information to make a treatment decision, or would joining this observational study add meaningful value to my care?
5Because this is an observational study with no Phase designation, it isn't testing whether trastuzumab deruxtecan works better than something else — so what would I actually gain by enrolling compared to simply receiving the drug as standard treatment if I qualify for it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.