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NCT04807595 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 798
- Enrollment target
NCT04807595: Completed study, sponsored by AstraZeneca.
NCT04807595 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 798 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04807595 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 798 participants
- Enrollment target
Study Summary
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.
Primary Outcome
To describe the overall prevalence and disease burden of HER2 low (IHC 1+, 2+/ISH-) among unresectable and/or mBC patients identified as HER2-neg, based on rescoring of historical HER2 fixed tissue IHC stained slides by Ventana 4B5 assay. The prevalence of HER2 low (IHC 1+, 2+/ISH-) at unresectable/metastatic BC diagnosis, determined based on rescoring of historical HER2 IHC slides locally, among patients confirmed to be HER2-neg (HER2 IHC zero and HER2 IHC 1+ and 2+/ISH-) by rescoring of histor
Interventions
- OTHER None (Observational study)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 798 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2022-04-26 |
What the finished NCT04807595 record still lists
NCT04807595 is an observational study that tracks outcomes without assigning an intervention. The registered 798 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which None (Observational study) is the first listed.
NCT04807595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04807595 about?
NCT04807595 is a clinical study titled "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". This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative (HER2-neg), regardless of hormone status.
What is the current status of trial NCT04807595?
This trial is currently completed. The enrollment target is 798 participants. The study started on 2021-05-28. Estimated completion is 2022-04-26.
What interventions are being tested in trial NCT04807595?
The interventions under investigation include: None (Observational study) (OTHER).
Who is sponsoring clinical trial NCT04807595?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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