Metastatic Breast Cancer Clinical Trial
— HER-TEMPOOfficial title:
Real World Study of TrEatment Discontinuations and Modifications for Patients With HER2+ and HER2-low Metastatic Breast Cancer On Trastuzumab Deruxtecan
NCT number | NCT06386263 |
Other study ID # | D9673R00032 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 22, 2024 |
Est. completion date | April 4, 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Research Site | Oakville | Ontario |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Daiichi Sankyo |
Canada,
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) |
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