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

Metastatic Breast Cancer Clinical Trial

— HER-TEMPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386263
• Other study ID #: D9673R00032
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: April 4, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 4, 2025
• Est. primary completion date: April 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Metastatic Breast Cancer
• Unresectable Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Canada	Research Site	Oakville	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Daiichi Sankyo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early treatment discontinuation rates	Summary statistics of cumulative number and proportion of patients discontinuing at each timepoint	3, 6, 9 months
Primary	Dose modifications	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	Real world time to treatment discontinuation (rwTTD)	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
Secondary	Reasons for treatment discontinuations	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
Secondary	Median treatment duration and dose intensity	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)