EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan Through a Named Patient Program (EUROPA T-DXd)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 256
- Locations
- 21
- Primary Endpoint
- Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
Study Overview
Brief Summary
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.
Detailed Description
The antibody-drug conjugate T-DXd has been granted conditional approval in the European Union as a single agent for adult patients with unresectable or metastatic HER2+ breast cancer who have previously received ≥2 HER2-based regimens. This was based on data from the Phase II DESTINY-Breast01 trial (NCT03248492).
DS8201-0002-EAP-MA is a real world data (RWD) observational data collection inviting patients with advanced/metastatic HER2+ breast cancer receiving T-DXd through the NPP already to participate to help further understand the usage in a real world clinical setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate.
Exclusion Criteria
- •Any participant who does not meet all inclusion criteria noted above.
Arms & Interventions
Trastuzumab Deruxtecan (T-DXd) Cohort
Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
Intervention: Trastuzumab deruxtecan (Drug)
Outcomes
Primary Outcomes
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
Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from trastuzumab deruxtecan initiation to discontinuation for any reason in patients with advanced/metastatic HER2+ breast cancer in a real-world clinical setting.
Secondary Outcomes
- Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)(Prior to time of T-DXd initiation)
- Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd(From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months)
- Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd)(From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months)
- Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd)(Prior to time of T-DXd initiation)
- Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)(From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months)