Study design for DESTINY-Breast Respond HER2-low Europe: T-DXd in patients with HER2-low advanced breast cancer

Area of Science:

• Oncology
• Pharmacology
• Clinical Research

Background:

• Trastuzumab deruxtecan (T-DXd) is an approved treatment for HER2-low metastatic breast cancer (mBC).
• Existing data on T-DXd efficacy and safety in HER2-low mBC primarily comes from controlled clinical trials.
• There is a need for real-world evidence to understand T-DXd's performance in routine clinical practice.

Purpose of the Study:

• To gather real-world data on the effectiveness, safety, and tolerability of T-DXd in HER2-low mBC patients.
• To investigate patient-reported outcomes, treatment patterns, and geriatric health status in this population.
• To provide insights that can improve clinical guidance for maximizing patient benefit from T-DXd therapy.

Main Methods:

• A multi-center, multi-country, observational, prospective, non-interventional study (DESTINY-Breast Respond HER2-low Europe, NCT05945732).
• Enrollment of 1350 patients across 216 sites in 12 European countries.
• Collection of data on patients receiving T-DXd or conventional chemotherapy in their standard care for advanced breast cancer.

Main Results:

• This section is not yet available as the study is prospective and data collection is ongoing.
• Real-world data on T-DXd effectiveness and safety in HER2-low mBC will be generated.
• Information on patient-reported outcomes, treatment patterns, and geriatric health will be collected.

Conclusions:

• Real-world data from this study will offer valuable insights into T-DXd treatment for HER2-low mBC.
• Findings will help refine clinical practice and improve treatment strategies for patients.
• The study aims to enhance the understanding of T-DXd's role in managing advanced HER2-low breast cancer.