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

NCT ID: NCT06386263

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2025-07-07

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

HER2-positive

This cohort includes patients with HER2+ mBC who started treatment with T-DXd in the PSP.

Trastuzumab deruxtecan

Intervention Type: 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.

HER2-low

This cohort includes patients with HER2-low mBC who started treatment with T-DXd in the PSP.

Trastuzumab deruxtecan

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

T-DXd; Enhertu

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Brezden-Masley

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Locations

Research Site

Oakville, Ontario, Canada

Countries

Canada

References

Brezden-Masley C, Qadeer R, Senhaji Mouhri Z, Salvo B, Bonar N, Spin P, Shokar S. Canadian real-world hybrid longitudinal cohort study of treatment discontinuations and modifications for patients with HER2+ and HER2-low metastatic breast cancer on trastuzumab deruxtecan enrolled in a patient support programme: the HER-TEMPO study protocol. BMJ Open. 2025 Sep 21;15(9):e100889. doi: 10.1136/bmjopen-2025-100889.

Reference Type: DERIVED

PMID: 40976668 (View on PubMed)

Other Identifiers

D9673R00032

Identifier Type: -

Identifier Source: org_study_id