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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
trial testing None (Observational study) in Breast Cancer in 798 participants. Completed in 26 April 2022.
26 April 2022
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 798 |
| Start date | 28 May 2021 |
| Primary completion | 26 April 2022 |
| Estimated completion | 26 April 2022 |
| Sites | 13 locations across France, Italy, Japan, United Kingdom, Germany, South Korea, Canada, Australia |
Drugs / interventions tested
- None (Observational study)
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT04807595
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04807595 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 6 March 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing