Clinical trial NCT05203458: Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients
Official title: HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer, HER2
Keywords: breast cancer,HER2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 3136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 3000 eligible breast cancer patients from about 10 medical sites in China from July 2021 to July 2022 and 200 patients admitted at FUSCC from January 1st 2015 to December 31st 2015. Eligible patients will be those who had qualified archived HER2 IHC slides.

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: The Prevalence of different HER2 expression levels
timeFrame: Within one year
Secondary outcomes:
measure: Tumor size of histopathological
timeFrame: Within one year
measure: Positive lymph node number of the histopathological
timeFrame: Within one year
measure: TNM stage by different HER2 expression levels
timeFrame: Within one year
measure: Pathological type of histopathological
timeFrame: Within one year
measure: Histological grade of histopathological
timeFrame: Within one year
measure: Multi-focal of histopathological
timeFrame: Within one year
measure: ER status of histopathological
timeFrame: Within one year
measure: ER percentage by different HER2 expression levels.
timeFrame: Within one year
measure: PR status of histopathological
timeFrame: Within one year
measure: PR percentage by different HER2 expression levels.
timeFrame: Within one year
measure: Ki-67 percentage by different HER2 expression levels.
timeFrame: Within one year
measure: HER2 IHC score of histopathological
timeFrame: Within one year
measure: FISH status of histopathological
timeFrame: Within one year
measure: The concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+)
timeFrame: Within one year
measure: The concordance of HER2 expression between manual and AI assisted HER2 interpretation
timeFrame: Within one year
measure: The concordance of HER2 expression between leading site (FUSCC) and other centers
timeFrame: Within one year
Other outcomes:
measure: The prevalence of HER2 IHC0 and HER2 IHC >0<1+
timeFrame: Within one year
measure: Age at diagnosis of patients' demographic at baseline
timeFrame: At baseline
measure: BMI of patients' demographic at baseline
timeFrame: At baseline
measure: Menopause or not of patients' demographic at baseline
timeFrame: At baseline
measure: The baseline treatment patterns across patients with different HER2 expression levels
timeFrame: At baseline
Locations:
city: Shanghai
country: China
facility: Research Site
state: Shanhai
city: Guangzhou
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
affiliation: Fudan University
name: Wentao Yang, Dr.
role: PRINCIPAL_INVESTIGATOR
References: