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NCT04807595

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

Completed Last updated 6 March 2023
What this trial tests

trial testing None (Observational study) in Breast Cancer in 798 participants. Completed in 26 April 2022.

Timeline
28 May 2021
Primary endpoint
26 April 2022
26 April 2022

Quick facts

Lead sponsorAstraZeneca
StatusCompleted
Study typeOBSERVATIONAL
Enrollment798
Start date28 May 2021
Primary completion26 April 2022
Estimated completion26 April 2022
Sites13 locations across France, Italy, Japan, United Kingdom, Germany, South Korea, Canada, Australia

Drugs / interventions tested

Conditions studied

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Standardized pathology report for HER2 testing in compliance with 2023 ASCO/CAP updates and 2023 ESMO consensus statements on HER2-low breast cancer.
    Ivanova M, Porta FM, D'Ercole M, Pescia C, et al · · 2024 · cited 66× · PMID 37770765 · DOI 10.1007/s00428-023-03656-w
  2. Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer.
    Viale G, Basik M, Niikura N, Tokunaga E, et al · · 2023 · cited 65× · PMID 37562195 · DOI 10.1016/j.esmoop.2023.101615
  3. Think "HER2" different: integrative diagnostic approaches for HER2-low breast cancer.
    Marchiò C, Criscitiello C, Scatena C, Santinelli A, et al · · 2023 · cited 14× · PMID 38180137 · DOI 10.32074/1591-951x-942
  4. Applications and challenges of utilizing digital pathology and AI-enabled workflows in clinical trials.
    Sebastian M, Batra H, Saini ML, Kearney S, et al · · 2026 · cited 1× · PMID 41631127 · DOI 10.1016/j.jpi.2025.100542

Verify or expand the search:

Other trials of None (Observational study)

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other AstraZeneca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04807595.

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