HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada

Sponsor
AstraZeneca
Study ID
NCT06386263
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    This is a non-interventional, observational study. Patients who are enrolled by their clinician will receive T-DXd per routine clinical practice through the PSP.

Study Details

Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively. Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings.

Key Dates

Start date
Apr 22, 2024
Status verified
Oct 2025
Primary completion
Jul 7, 2025
Completion
Jul 7, 2025

Study Design

Enrollment
22 participants (actual)

Arms

  • Arm: HER2-positive
    This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP.
  • Arm: HER2-low
    This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP.

Primary Outcome Measure

Early treatment discontinuation rates [ Time Frame: 3, 6, 9 months ]

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