HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada (NCT06386263) | Clinical Trial Compass
CompletedNot Applicable
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Canada22 participantsStarted 2024-04-22
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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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 Intersti…
What they're measuring
1
Early treatment discontinuation rates
Timeframe: 3, 6, 9 months
2
Dose modifications
Timeframe: 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)