Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386263
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-03
Brief Title:
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2 and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HER-TEMPO
Brief 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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None