Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
NCT ID: NCT06961331
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
86 participants
OBSERVATIONAL
2025-05-07
2025-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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3L+4L tucatinib triplet patients
Non-interventional, retrospective cohort analysis of participants receiving the tucatinib triplet in the 3L or 4L setting immediately following T-DXd.
Tucatinib
As provided in real world practice.
Trastuzumab
As provided in real world practice.
Capecitabine
As provided in real world practice.
Interventions
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Tucatinib
As provided in real world practice.
Trastuzumab
As provided in real world practice.
Capecitabine
As provided in real world practice.
Eligibility Criteria
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Inclusion Criteria
2. Evidence of human epidermal growth factor receptor 2 (HER2) receptor positivity prior to or up to 90 days following the mBC diagnosis date
3. At least 18 years old on the mBC diagnosis date
4. Treated with systemic anticancer treatment in the metastatic setting, i.e., post mBC diagnosis.
5. 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 Criteria
1. 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)
2. Patients treated with tucatinib prior to T-DXd
3. Patients participating in clinical trials
4. Patients receiving concomitant endocrine therapy on index line
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
New York, New York, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4251025
Identifier Type: -
Identifier Source: org_study_id
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