EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
- Sponsor
- Daiichi Sankyo
- Study ID
- NCT05458401
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab deruxtecan — DRUGNo drug will be administered during this study.
Study Details
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.
Key Dates
- Start date
- Nov 11, 2022
- Status verified
- Mar 2024
- Primary completion
- Dec 1, 2023
- Completion
- Dec 1, 2023
Study Design
- Enrollment
- 256 participants (actual)
Arms
- Arm: Trastuzumab Deruxtecan (T-DXd) CohortPatients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
Primary Outcome Measure
Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd) [ Time Frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months ]
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