SOLTI-2309 RESISTHER
Real World Evidence (RWE) Program
Real-World Efficacy outcomes With Tucatinib for HER2-Positive Advanced Breast Cancer Immediately After Trastuzumab Deruxtecan (DS-8201)
Status
Tumour subtype:
Scenario
Observational study with medicines for human use
SPONSOR
SOLTI
COLLABORATORS
PRINCIPAL INVESTIGATORS
Dr. Rodrigo Sanchez-Bayona
Medical Oncology Dpt. Breast Cancer Unit University Hospital 12 de Octubre, Madrid, Spain
Dr. Bartomeu Fullana Grimalt
Medical Oncology, Institut Català d'Oncologia L'Hospitalet de Llobregat, Barcelona, Spain
Dra. Lucia Sanz Gómez
Medical Oncology Service Hospital H. Universitario de Torrejón y Hospital Beata María Ana Madrid, Spain
This study aims to address the following overarching research question: What are the clinical characteristics, treatment patterns, healthcare resource utilization, and outcomes of patients diagnosed with breast cancer in real-world settings in Spain?
By addressing this question, the study seeks to understand how breast cancer is managed in routine clinical practice in Spain, identify potential variations in care, and generate information that can inform healthcare policies, clinical guidelines, and patient-centered care models.
Methodologically, this project will utilize previously collected data from routine clinical practice. Each aspect of the project will be carried out by a healthcare team using data previously collected during their patient care. SOLTI will centrally monitor the quality of the data.
The primary data sources are expected to be electronic health records, pharmacy records, medical records, and other hospital records for patients.
Sites
The study data are collected in pseudonymized format and processed exclusively for scientific purposes, in accordance with Regulation (EU) 2016/679 (GDPR) and Organic Law 3/2018, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
The data will be retained for 25 years in accordance with biomedical research regulations. SOLTI and the participating healthcare centers, each within their respective areas of responsibility, are responsible for data processing.
In compliance with Additional Provision 17 of the LOPDGDD, an exemption from informed consent has been requested. Furthermore, a Data Protection Impact Assessment and a Legitimate Interest Assessment have been carried out, which support the lawfulness, necessity, and proportionality of the processing in the context of this study.
Interested parties may exercise their rights of access, rectification, erasure, limitation of processing or opposition, through the following email address: protecciondedatos@gruposolti.org
