An observational study in HER2-positive Breast Cancer, sponsored by Daiichi Sankyo. Completed at 21 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Daiichi Sankyo · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 256 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The real world data (RWD) collection will include adult participants with advanced/metastatic HER2+ breast cancer treated in routine clinical practice. The collection of RWD will be optional and independent to eligibility for the NPP. It will include those who have already completed T-DXd treatment under the NPP, as well as patients whose T-DXd treatment remains ongoing.
Exclusion Criteria:
Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
Drug: Trastuzumab deruxtecan
No drug will be administered during this study.
Also known as: T-DXd
Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
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.
Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
Time frame: Prior to time of T-DXd initiation
Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd
Time frame: 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)
Time frame: 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)
Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.
Time frame: Prior to time of T-DXd initiation
Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
Real world progression-free survival (rwPFS) is defined as the time from T-DXd initiation to the earliest of death or progression.
Time frame: From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Daiichi Sankyo