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 (BEYOND)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: TDxd

• Study Type: Observational
• Enrollment (Estimated): 109

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Research Site
  • Al Ain City, United Arab Emirates
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of adult (age ≥ 18 years old at the date of T-DXd initiation) female patients with a confirmed diagnosis of HR-positive, HER2-low (defined as immunohistochemistry [IHC] 1+ or IHC 2+/In situ hybridization [ISH]-) or HER2-ultralow (IHC 0 with membrane staining) mBC that has progressed on one or more ET in the metastatic setting and initiated T-DXd up to 30 days before the index date.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
real-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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	18 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; Trastuzumab Deruxtecan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: D7814R00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes