NCT05217381

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18,533 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Early Breast Cancer
• Metastatic Breast Cancer
• Locally Advanced Breast Cancer

Timeline

• Start date: 2022-02-22
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2022-02-01
• Last updated: 2023-09-25

Locations

7 sites across 1 country: Spain