Skip to main content
OpenTrials
Completed

NCT Number: NCT05458401

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HER2-positive Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's Private Hospital, Dublin, Ireland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate.

Exclusion criteria

  • Any participant who does not meet all inclusion criteria noted above.

Treatment and study plan

Trastuzumab Deruxtecan

Drug

No drug will be administered during this study.

Other names: T-DXd

Primary outcomes

  1. Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

    Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

    Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from trastuzumab deruxtecan initiation to discontinuation for any reason in patients with advanced/metastatic HER2+ breast cancer in a real-world clinical setting.

Secondary outcomes

  1. Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

    Time frame: Prior to time of T-DXd initiation

  2. Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd

    Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

  3. Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

    Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

  4. Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

    Time frame: Prior to time of T-DXd initiation

    Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.

  5. Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

    Time frame: From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months

    Real world progression-free survival (rwPFS) is defined as the time from T-DXd initiation to the earliest of death or progression.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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)

Acronym: EUROPA T-DXd

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.