NCT05458401

EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan

EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan Through a Named Patient Program (EUROPA T-DXd)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 256 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.

Detailed description

The antibody-drug conjugate T-DXd has been granted conditional approval in the European Union as a single agent for adult patients with unresectable or metastatic HER2+ breast cancer who have previously received ≥2 HER2-based regimens. This was based on data from the Phase II DESTINY-Breast01 trial (NCT03248492). DS8201-0002-EAP-MA is a real world data (RWD) observational data collection inviting patients with advanced/metastatic HER2+ breast cancer receiving T-DXd through the NPP already to participate to help further understand the usage in a real world clinical setting.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	No drug will be administered during this study.

Timeline

• Start date: 2022-11-11
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-07-14
• Last updated: 2024-03-15

Locations

21 sites across 3 countries: Ireland, Italy, Spain

Regulatory

• FDA-regulated drug study