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

NCT07597993 | Not Yet Recruiting FDA Drug

• 1 other identifier: D7814R00001
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; Trastuzumab Deruxtecan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• safety profile

  18 months

• baseline patient characteristics

  18 months

• T-DXd treatment patterns

  18 months

• real-world time to next treatment (TTNT)

  18 months

Interventions

TDxd DRUG

Observing Trastuzumab Deruxtecan in Patients with HR positive, HER2-low or Ultra-low Metastatic Breast Cancer Previously Treated with Endocrine Therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients aged ≥18 years old at the time of T-DXd initiation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Abu Dhabi, United Arab Emirates

Location

Research Site

Al Ain City, United Arab Emirates

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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
• 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

Locations

AE (2)