NCT06961331Completed
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
Real-world Clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan for the Treatment of HER2-postive Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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, time to discontinuation, and overal survival) of the tucatinib-trastuzumab-capecitabine triplet therapy immediately following T-DXd therapy in patients diagnosed with HER2+ metastatic breast cancer (mBC) in the United States.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 86 (actual)
- First submitted
- 29 Apr 2025
- Start date
- 7 May 2025
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Pfizer
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06961331
What you commit to
- Study type: Observational
- Participants enrolled: 86
- From 7 May 2025 to the primary completion date, 25 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 receiving concomitant endocrine therapy on index line
Other
- Patients meeting any of the following criteria will not be included in the study:
- Patients participating in clinical trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.