NCT06833268Completed
Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan
Real-world Outcomes of Patients With HER2-positive (HER2+) Metastatic Breast Cancer (mBC) After Treatment With Trastuzumab Deruxtecan (T-DXd) in the United States
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 228 (actual)
- First submitted
- 12 Feb 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- Daiichi Sankyo
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06833268
What you commit to
- Study type: Observational
- Participants enrolled: 228
- From 20 Jan 2025 to the primary completion date, 16 Jun 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.
Who the study is looking for
- Patients must meet all the inclusion criteria below to be included in the study population:
- Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011.
- Patients aged ≥18 years old at mBC diagnosis date.
- Patients with ≥1 T-DXd-containing LOT in the metastatic setting.
- Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date.
- Patients whose closest HER2 test result (defined as immunohistochemistry \[IHC\] 3+ or in situ hybridization \[ISH\]+) recorded prior to or on the index date was a HER2+ test result.
- Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flatiron Health, Inc 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.