Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

CompletedOBSERVATIONAL
Enrollment

798

Participants

Timeline

Start Date

May 28, 2021

Primary Completion Date

April 26, 2022

Study Completion Date

April 26, 2022

Conditions
Breast Cancer
Interventions
OTHER

None (Observational study)

The data source for this project will be HER2 IHC historical scores, local lab rescoring of historical HER2 fixed tissue slides, independent central retesting or local lab retesting (under special occasions) of HER2 IHC status for enrolled patients who have available tissue, other biomarker testing results based on historical testing and/or testing of archived tissue samples when available, and curated patient-level data. Real-world data sources include electronic health records/electronic medical records (EHR/EMR) and biobank registries. Data from EHR/EMR sources will be curated. Biobank tissue for enrolled patients who have multiple samples available will be selected consecutively when possible and will start with the latest available samples then move backward in time.

Trial Locations (13)

15213

Research Site, Pittsburgh

20141

Research Site, Milan

63011

Research Site, Clermont-Ferrand

91054

Research Site, Erlangen

Unknown

Research Site, Melbourne

H3T 1R2

Research Site, Montreal

104-8560

Research Site, Chūōku

811-1395

Research Site, Fukuoka

259-1193

Research Site, Isehara

1649-035

Research Site, Lisbon

4200-319

Research Site, Porto

03722

Research Site, Seoul

M20 4BX

Research Site, Manchester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

AstraZeneca

INDUSTRY