Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan

Completed

Conditions studied: HER2-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT06833268

Run by

Daiichi Sankyo

People needed

228

Starts

2025-01-20

Expected to finish

2025-06-16

Last updated by the study team

2025-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Exclusion Criteria No exclusion criteria will be imposed.

Where it is running

• Flatiron Health, Inc — New York, New York, United States

Full record on ClinicalTrials.gov

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