NCT06386263

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

Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2+ and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-interventional, observational, hybrid (involving both primary and secondary data), cohort study that is utilizing patient support program (PSP) data. PSPs in Canada can support patients in accessing medicines after Health Canada has granted marketing authorization of a new drug or new indication before public reimbursement is available. The outcomes will be assessed for the HER2-positive and HER2-low cohorts separately. The primary objectives include assessing early treatment discontinuation rates at 3-, 6-, and 9-months after initiating T-DXd, and characterizing T-DXd dose modifications (i.e., interruptions and reductions) over the course of treatment for HER2+ mBC and HER2-low mBC. Secondary objectives include estimating the real-world time to discontinuation (rwTTD) of T-DXd, reasons for treatment discontinuations, and real world duration of treatment and dose intensity with T-DXd. The primary analysis population for all primary and secondary objectives will be the Total PSP Population (TPP), which includes all patients enrolled into the PSP who meet study criteria. Sensitivity analyses will also be performed in the Study PSP population (SPP), which will be a subset of patients from the TPP who provide study consent for additional data collection.

Conditions

• Unresectable Breast Cancer
• Metastatic Breast Cancer
• HER2-low Expressing Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	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.

Timeline

• Start date: 2024-04-22
• Primary completion: 2025-07-07
• Completion: 2025-07-07
• First posted: 2024-04-26
• Last updated: 2025-10-15

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study