SMART EUCAN
Research type
Research Study
Full title
Observational Study into Treatment Patterns, Safety Management, and Effectiveness of T-DXd in Patients with HER2-positive Metastatic Breast Cancer in Europe and Canada: SMART EUCAN
IRAS ID
370403
Contact name
Maki Inoue-Choi
Contact email
Sponsor organisation
ASTRAZENECA
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
This is a multi-country, multi-site, non-interventional, observational study, with retrospective data collection to describe trastuzumab deruxtecan (T-DXd) treatment patterns, including dose reduction, treatment interruption, discontinuation, overall and by index line of therapy (LOT) among patients with HER2+ metastatic breast cancer (mBC) who received T-DXd in the second line (2L) and third line (3L) (and possibly fourth line (4L), subject to recruitment rates) in the metastatic setting.
Secondary objectives will include describing demographic and clinical characteristics of patients who received T-DXd in the metastatic setting, including adverse events (AEs), proportion of patients with AEs and time to AEs during T-DXd treatment, any changes in T-DXd treatment patterns, including treatment modification (interruption or dose reduction) and treatment discontinuation following AE occurrence, overall and by index LOT, as well as characterize pre- and post-T-DXd treatment and treatment sequences by index LOT.
The study will be conducted in cancer treatment centers in 4 countries, including UK, France, Spain and Canada, and is expected to comprise a minimum of 125 patients per European country and approximately 250 patients in Canada, for a total of 625 patients. The study period will be between 31st May 2021 and 1st April 2026. Adult patients (≥18 years) at the index date (defined as initiation date of T-DXd administered either as monotherapy or in combination therapy in the metastatic setting), will be eligible for the study (data collection). Those patients with discrepant results for HER2 status from the most recent test before or on the index date, with no patient observations (e.g., records of visits, treatments, diagnoses) after index date and/or received T-DXd for mBC as part of a clinical trial prior to or during the index LOT, won’t be eligible for the study. All analyses will be descriptive in nature except for analyses relating to time-to-event analyses.
REC name
N/A
REC reference
N/A