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

March 13, 2024 updated by: Daiichi Sankyo

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Contact for Clinical Trial Information
  • Phone Number: 908-992-6400
  • Email: CTRinfo@dsi.com

Study Locations

  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St. Vincent's University Hospital
      • Dublin, Ireland, D04 N2EO
        • St. Vincent's Private Hospital
  • Italy
      • Naples, Italy, 80131
        • National Cancer Instutute 'Fondazione Pascale
      • Padua, Italy, 35128
        • Institute Oncology Veneto
      • Rome, Italy, 00128
        • Università Campus Bio-Medico di Roma
      • Rome, Italy, 00161
        • Policlinico Umberto I Di Roma
      • Rome, Italy, 00168
        • Fondazione Policlinico Univeritario Agostino Gemeli
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Centro di riferimento Oncologico (CRO), National Cancer Institute
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Val d'Hebron
      • Barcelona, Spain, 08023
        • Hospital Quiron Salud Barcelona
      • Gerona, Spain, 17007
        • ICO Girona
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano de Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The real world data (RWD) collection will include adult participants with advanced/metastatic HER2+ breast cancer treated in routine clinical practice. The collection of RWD will be optional and independent to eligibility for the NPP. It will include those who have already completed T-DXd treatment under the NPP, as well as patients whose T-DXd treatment remains ongoing.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trastuzumab Deruxtecan (T-DXd) Cohort
Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
Drug: Trastuzumab deruxtecan
No drug will be administered during this study.
Other Names:
  • T-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
Time Frame: Prior to time of T-DXd initiation
Prior to time of T-DXd initiation
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
From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
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
From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
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.
Prior to time of T-DXd initiation
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.
From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-0002-EAP-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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