Status:
COMPLETED
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
Lead Sponsor:
Pfizer
Conditions:
Metastatic HER2+ Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g. time to next treatment, ...
Eligibility Criteria
Inclusion
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- mBC diagnosis between January 1, 2017 and 6 months prior to database cutoff
- Evidence of human epidermal growth factor receptor 2 (HER2) receptor positivity prior to or up to 90 days following the mBC diagnosis date
- At least 18 years old on the mBC diagnosis date
- Treated with systemic anticancer treatment in the metastatic setting, i.e., post mBC diagnosis.
- Treated with T-DXd in the 1L or 2L or 3L setting, followed immediately by the tucatinib triplet, and at least 1 additional prior HER2-targeted regimen
Exclusion
- Patients meeting any of the following criteria will not be included in the study:
- Patients with evidence of other cancers six months prior to the mBC diagnosis date will be identified with the following International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes in all databases: 140.xx - 195.xx, 200.xx - 208.xx, C00.xx - C76.xx, C81.xx - C96.xx. (exclude - ICD-9: 174.X, 175.X; ICD-10: C50.XX)
- Patients treated with tucatinib prior to T-DXd
- Patients participating in clinical trials
- Patients receiving concomitant endocrine therapy on index line
Key Trial Info
Start Date :
May 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 25 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06961331
Start Date
May 7 2025
End Date
September 25 2025
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer
New York, New York, United States, 10001