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Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status — RosHER  

Metastatic Breast Cancer Clinical Trial

Official title:
Retrospective Observational Study With Real-World Data to Assess Demographic and Clinicopathological Profiles, and Management of Breast Cancer Patients With Positive, Low or Negative Expression of HER2 in Spain

Clinical Trial Summary

This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).

Clinical Trial Description

Patients with pathologically documented an initial breast cancer diagnostic (early breast cancer (BC) or locally advanced BC or de novo metastatic BC) with documented human epidermal growth factor receptor 2 (HER2) and estrogen receptor (ER)/progesterone receptor (PgR) expression status at the time of diagnosis. Data to determine the primary endpoint is estimated to be derived from the EHRs of over 2,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo metastatic BC (mBC) between the 1st of January 2005 and the 31st of December 2021, and who had at least one subsequent relapse until the 31st of December 2021 in at least 10 clinical centers. The secondary endpoints utilize a larger collection of data from over 30,000 patients that have an initial diagnosis of early BC, or locally advanced BC, or de novo mBC between the 1st of January 2005 and the 31st of December 2021. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05217381
Study type Observational
Source MedSIR
Contact
Status Completed
Phase
Start date February 22, 2022
Completion date September 20, 2023
View Details
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