HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
NCT06386263 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22
Last updated 2025-10-15
Summary
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.
Conditions
- Unresectable Breast Cancer
- Metastatic Breast Cancer
- HER2-low Expressing Breast Cancer
- HER2-positive Breast Cancer
Interventions
- 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.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Christine Brezden-Masley · Sinai Health System
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-22
- Primary Completion
- 2025-07-07
- Completion
- 2025-07-07
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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