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

October 14, 2025 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6H1A7
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable or metastatic HER2-positive or HER2-low breast cancer enrolled in the PSP who started treatment with T-DXd.

Description

Inclusion Criteria:

Enrollment criteria for HER2-positive PSP:

  • Adults, 18 years of age or older
  • Unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy
  • Patients must not have received a prior anti-HER2 ADC, such as trastuzumab emtansine, in the metastatic setting
  • Patients who received a prior anti-HER2 ADC in the adjuvant setting must have progressed >12 months following the completion of therapy

Enrollment criteria for HER2-low PSP:

  • Adults, 18 years of age or older
  • Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • Patients with HR+ breast cancer should have received at least one or be considered ineligible for endocrine therapy.

Patients in the SPP must additionally meet the following criteria:

  • Patients must have provided consent to be contacted for future research and provided consent to participate in the current observational study

Exclusion Criteria (both cohorts):

  • Patients who enrolled in the PSP, but did not initiate therapy with T-DXd by the end of the PSP program
  • Patients with medical history of Interstitial Lung Disease (ILD) / pneumonitis that required steroids or current ILD /pneumonitis
  • Patients who do not have adequate renal or hepatic function, defined as:
  • Inadequate renal function is defined as Creatinine clearance <30 mL/min, as calculated using the Cockcroft-Gault equation .
  • Inadequate hepatic function is aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >5 × upper limit of normal (ULN). Total bilirubin >1.5 × ULN if no liver metastases or ≥ 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HER2-positive
This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP.
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.
Other Names:
  • Enhertu
  • T-DXd
HER2-low
This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP.
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.
Other Names:
  • Enhertu
  • T-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early treatment discontinuation rates
Time Frame: 3, 6, 9 months
Summary statistics of cumulative number and proportion of patients discontinuing at each timepoint
3, 6, 9 months
Dose modifications
Time Frame: from baseline to treatment discontinuation or the end of PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
Summary statistics about number and proportion of patients experiencing a dose modification (reduction or interruption) while receiving treatment in the PSP
from baseline to treatment discontinuation or the end of PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Real world time to treatment discontinuation (rwTTD)
Time Frame: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Median time from first dose of T-DXd to earliest date of T-DXd discontinuation as recorded in the patient support program (PSP) database or self-report from follow-up, or death, whichever occurs first
from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Reasons for treatment discontinuations
Time Frame: from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Summary statistics about the number and proportion of patients with pre-specified reasons for treatment discontinuations as recorded by the clinician in the PSP program or based on self-report
from baseline to treatment discontinuation (self-report or recorded in the PSP database), end of the PSP, or end of the study period, assessed up to 24 months
Median treatment duration and dose intensity
Time Frame: from baseline to treatment discontinuation (as recorded in the PSP database) or end of the PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)
Median treatment duration (and range, 95% CI): time from treatment initiation to treatment discontinuation excluding any dose interruptions; and dose intensity (DI) will be measured by the total drug delivered over the total time for the course of treatment (RDI will be the ratio of DI to the standard dose intensity)
from baseline to treatment discontinuation (as recorded in the PSP database) or end of the PSP, assessed up to 12 months (HER2-positive cohort) and up to 14 months (HER2-low cohort)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo

Investigators

  • Principal Investigator: Christine Brezden-Masley, Sinai Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Actual)

July 7, 2025

Study Completion (Actual)

July 7, 2025

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9673R00032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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