EUROPA T-DXd – EUropean Real-world experience of previously treated advanced/metastatic HER2-positive breast cancer patients accessing trastuzumab deruxtecan through a named patient programme

This study is being done to collect and analyse demographic data, clinical characteristics and efficacy of treatment of T-DXd in patients with advanced/metastatic HER2-positive breast cancer

We’re pleased to announce that recruitment for EUROPA T-DXd has successfully concluded. We extend our heartfelt gratitude to all participants and supporters for their invaluable contribution.

Key Eligibility Criteria

The aim of this observational research is to collect and analyse demographic data, clinical characteristics and efficacy of treatment of the medication called trastuzumab deruxtecan (T-DXd) in patients with advanced/metastatic HER2-positive breast cancer included in the Named Patient Programme (NPP) with T-DXd (DS8201-0002-EAP-MA).

This data collection study is open both to those subjects who are still on treatment and those who have completed the treatment within the T-DXd NPP; the participation is entirely optional and independent of the supply of the medication.

Collection of the data as part of your participation in the NPP may provide important information from which future patients may benefit as well as provide additional knowledge about patient populations. Therefore, the key objective of collecting the data is to understand how T-DXd treatment works for a wider population of patients.

In particular, with the research project that we are presenting here, we intend to obtain data from the start of patient’s treatment with T-DXd within the NPP until discontinuation or until the end of this observational study’s data collection period.

The processing of the personal data will be in compliance with the Data Protection Acts 1988 to 2018 (as amended) and the General Data Protection Regulation (the “Data Protection Legislation”). More information regarding data protection.

The potential patients for this study have been treated under the NPP (name patient programme) and are already identified by the investigators, this information available in other platform is not applicable for this NIS.

Contact: Jo Ballot, Clinical Research Manager

Therapeutic Area

Advanced/metastatic HER2-positive breast cancer

Type of Study

Observational research

Study Status

Open Recruiting

Sponsor

Daiichi Sankyo Inc.

Principal Investigator

Prof Walshe

Contact

ccrt@svuh.ie