Spots Global Cancer Trial Database for EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
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Trial Identification
Brief Title: EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
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)
Study ID: NCT05458401
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Vincent's Private Hospital, Dublin, , Ireland
St. Vincent's University Hospital, Dublin, , Ireland
Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas, Rozzano, Milano, Italy
Centro di riferimento Oncologico (CRO), National Cancer Institute, Aviano, Pordenone, Italy
National Cancer Instutute 'Fondazione Pascale, Naples, , Italy
Institute Oncology Veneto, Padua, , Italy
Universita Campus Bio-Medico Di Roma, Rome, , Italy
Policlinico Umberto I Di Roma, Rome, , Italy
Fondazione Policlinico Univeritario Agostino Gemeli, Rome, , Italy
Hospital General Universitario De Alicante, Alicante, , Spain
Hospital Del Mar, Barcelona, , Spain
Hospital Quiron Salud Barcelona, Barcelona, , Spain
Hospital Val d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
ICO Girona, Gerona, , Spain
Hospital Universitario de Jaen, Jaén, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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