Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients

Study Overview
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Brief Summary
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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

Detailed Description
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This is a multicenter, retrospective study 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. This study will be divided into two parts： The first part will include 200 subjects who were pathologically diagnosed with breast cancer at FUSCC between Jan 2015 and Dec 2015 (PART 1).This part will collect rescored HER2 expression level results based on the archived HER2 IHC slides and re-staining and re-scoring HER-2 IHC while relative demographic, treatment, and clinicopathologic data will be extracted from the FUSCC Breast Cancer Single Disease Database. The second part will include 3000 patients from all sites in China who were pathologically diagnosed with breast cancer between July 2021 and July 2022 (PART 2). This part will collect re-assessed HER2 expression level results based on the archived HER2 IHC slides. The general information of patients, diagnosis, clinicopathological information were collected from medical records, Hospital Information System (HIS) and Laboratory Information Management System (LIS). In PART 2, among 3000 patients, 270 from all participating sites except FUSCC should have enough tumor tissue for re-staining and re-scoring HER-2 IHC at FUSCC to analyse the concordance between leading site and other centers. In PART 2, among 3000 patients, 800 HER-2 IHC samples will be selected for the validation through AI-assisted HER2 assessment system

Official Title
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HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)

Conditions
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Breast Cancer, HER2

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Prevalence of different HER2 expression levels | 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. | Within one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor size of histopathological | Tumor size of Histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| Positive lymph node number of the histopathological | Positive lymph node number of histopathological characteristic by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| TNM stage by different HER2 expression levels | TNM stage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| Pathological type of histopathological | Pathological type by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| Histological grade of histopathological | Histological grade by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| Multi-focal of histopathological | Multi-focal by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| ER status of histopathological | ER status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| ER percentage by different HER2 expression levels. | ER percentage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| PR status of histopathological | PR status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| PR percentage by different HER2 expression levels. | PR(Progesterone Receptor) percentage by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| Ki-67 percentage by different HER2 expression levels. | Histopathological and clinicopathological characteristics by different HER2 expression level (Ø /Low/High) including: Ki-67 percentage,in PART 1 and PART 2 | Within one year | 
| HER2 IHC score of histopathological | HER2 IHC score by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| FISH status of histopathological | FISH status by different HER2 expression level (Ø /Low/High) in PART 1 and PART 2 | Within one year | 
| The concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+) | To estimate the concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+) in PART 2 | Within one year | 
| The concordance of HER2 expression between manual and AI assisted HER2 interpretation | To estimate the concordance of HER2 expression between manual and AI assisted HER2 interpretation among 800 patients in PART 2 | Within one year | 
| The concordance of HER2 expression between leading site (FUSCC) and other centers | To estimate the concordance of HER2 expression between leading site (FUSCC) and other centers among 270 patients in PART 2 | Within one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer,HER2