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

AstraZeneca

Status

Active, not recruiting

Conditions

Unresectable Breast Cancer

HER2-low Expressing Breast Cancer

HER2-positive Breast Cancer

Metastatic Breast Cancer

Treatments

Drug: Trastuzumab deruxtecan

Study type

Observational

Funder types

Industry

Identifiers

NCT06386263

D9673R00032

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 (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.