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RecruitingNCT07597993BEYONDUpdated Sep 23, 2026

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

An observational study in Breast Cancer, sponsored by AstraZeneca. Recruiting at 9 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
109
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • Trastuzumab Deruxtecan
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
109 participants (estimated)
Patient registry
No

Interventions

  • DrugTDxd

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

05

What researchers measure

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

    Time frame: 18 months

Secondary outcomes

  1. 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.

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

  3. 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.

    Time frame: 18 months

  4. 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

    Time frame: 18 months

06

Study locations

1 of 9 sites 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
    Recruiting
  • Research Site
    Riyadh, Saudi Arabia
    Not yet recruiting
  • Research Site
    Abu Dhabi, United Arab Emirates
    Not yet recruiting
  • Research Site
    Al Ain City, United Arab Emirates
    Not yet recruiting
  • Research Site
    Dubai, United Arab Emirates
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07597993
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 20, 2026
Start date
Jul 12, 2026
Primary completion
Mar 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Study Information Center
Contact
information.center@astrazeneca.com
+18772409479

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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