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

HER2-positive Breast Cancer Clinical Trial

— EUROPA T-DXd  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458401
• Other study ID #: DS8201-0002-EAP-MA
• Status: Completed
• Start date: November 11, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Trastuzumab deruxtecan
No drug will be administered during this study.

Locations

Country	Name	City	State
Ireland	St. Vincent's Private Hospital	Dublin
Ireland	St. Vincent's University Hospital	Dublin
Italy	Centro di riferimento Oncologico (CRO), National Cancer Institute	Aviano	Pordenone
Italy	National Cancer Instutute 'Fondazione Pascale	Naples
Italy	Institute Oncology Veneto	Padua
Italy	Fondazione Policlinico Univeritario Agostino Gemeli	Rome
Italy	Policlinico Umberto I Di Roma	Rome
Italy	Universita Campus Bio-Medico Di Roma	Rome
Italy	Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas	Rozzano	Milano
Spain	Hospital General Universitario De Alicante	Alicante
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Quiron Salud Barcelona	Barcelona
Spain	Hospital Val d'Hebron	Barcelona
Spain	ICO Girona	Gerona
Spain	Hospital Universitario de Jaen	Jaén
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Fundacion Instituto Valenciano de Oncologia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Countries where clinical trial is conducted

Ireland,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)	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	Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)		Prior to time of T-DXd initiation
Secondary	Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd		From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
Secondary	Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd)		From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
Secondary	Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd)	Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.	Prior to time of T-DXd initiation
Secondary	Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)	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