Clinical trial · Observational
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
NCT06833268CI-TRIAL-00091831completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drug | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-positive breast cancer
- description
- Patients diagnosed with HER2-positive metastatic breast cancer who initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting.
- interventionNames
- Other: No drug
Primary outcomes (1)
- measure
- Real-world Progression-free Survival (rwPFS)
- timeFrame
- Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months
- description
- rwPFS is defined as the interval in months between the index date until the first evidence of progression or death as documented by Flatiron.
Secondary outcomes (3)
- measure
- Real-world Time to Next Treatment (rwTTNT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Patients must meet all the inclusion criteria below to be included in the study population: 1. Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011. 2. Patients aged ≥18 years old at mBC diagnosis date. 3. Patients with ≥1 T-DXd-containing LOT in the metastatic setting. 4. 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. 5. 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. 6. Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024). Exclusion Criteria No exclusion criteria will be imposed.
References
Publications (0)
Data not yet available
No reference posted for this study.