Clinical trial · Observational
Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients
HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
NCT05203458CI-TRIAL-00077227HER2 PATHcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This retrospective study aims to estimate the prevalence of different HER2 expression levels (HER2+, HER2-low, HER2 Ø) in approximately 200 breast cancer patients at FUSCC through the year of 2015 and 3000 breast cancer patients from about 10 medical centres in China between July 2021 and July 2022
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, HER2 | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The Prevalence of different HER2 expression levels
- timeFrame
- Within one year
- description
- To estimate the prevalence of different HER2 expression levels (HER2+, HER2-low(defined as IHC 1+,2+/ISH-), HER2 Ø) in Chinese breast cancer patients in PART 2.
Secondary outcomes (16)
- measure
- Tumor size of histopathological
- timeFrame
- Within one year
- description
- Tumor size of Histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
- measure
- Positive lymph node number of the histopathological
- timeFrame
- Within one year
- description
- Positive lymph node number of histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients fulfilling all of the following criteria will be eligible for this study: * Male and female patients must have a histological confirmed diagnosis of BC * The patients must be ≥18 years old at the diagnosis. * In PART 1, all patients should be diagnosed at FUSCC between Jan 2015 and Dec 2015. * In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July 2022. * Provision of at least 1 archived HER2 IHC slides associated with confirmed diagnosis of BC, which are in good condition for rescoring. * FISH result is available for HER2 IHC2+ in primary scoring. Exclusion Criteria: Patients who meet any of the following criteria will be disqualified from entering the study: * Absence of all demographic, histopathologic, clinicopathologic information . * Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
References
Publications (1)
- DERIVEDLv H, Yue J, Zhang Q, Xu F, Gao P, Yang H, Nie X, Kong L, Zhang G, Li J, Xiao S, Wu H, Xing A, Hong M, Fan J, Guan H, Cao P, Ni H, Yang W. Prevalence and concordance of HER2-low and HER2-ultralow status between historical and rescored results in a multicentre study of breast cancer patients in China. Breast Cancer Res. 2025 Mar 25;27(1):45. doi: 10.1186/s13058-025-02001-0. PMID 40134013