BEYOND: Real-world use of Trastuzumab Deruxtecan in HR-positive, HER2-low/ultralow metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BEYOND is an observational study that will collect real-world data from GCC countries to describe patient characteristics, treatment patterns, survival, and safety of Trastuzumab Deruxtecan in this specific breast cancer group. It aims to inform clinical practice and guidelines by examining how the drug is used outside of clinical trials and what outcomes are seen in routine care. Eligible patients are adult women who started T-DXd and meet the HER2-low/ultralow criteria after prior endocrine therapy, without mandated randomization or intervention beyond standard clinical practice. Data will be drawn from medical records at participating sites to reflect everyday treatment decisions. Results will help clinicians understand real-world effectiveness and safety of T-DXd in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Riyadh, Saudi Arabia Recruiting
• Research Site
  Muscat, Oman Not yet recruiting
• Research Site
  Doha, Qatar Not yet recruiting
• Research Site
  Mecca, Mecca Region, Saudi Arabia Not yet recruiting
• Research Site
  Jeddah, Saudi Arabia Not yet recruiting
• Research Site
  Riyadh, Saudi Arabia Not yet recruiting

Study contacts

• Study coordinator: Study Information Center
• Email: information.center@astrazeneca.com
• Phone: +18772409479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.