HER2 Retrospective Epidemiology Study Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients (HER2 PATH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,136
- 试验地点
- 1
- 主要终点
- The Prevalence of different HER2 expression levels
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •In PART 2, all patients should be diagnosed at all participating sites between July 2021 and July
- •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.
排除标准
- •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.
结局指标
主要结局
The Prevalence of different HER2 expression levels
时间窗: Within one year
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.
次要结局
- TNM stage by different HER2 expression levels(Within one year)
- Tumor size of histopathological(Within one year)
- ER status of histopathological(Within one year)
- Ki-67 percentage by different HER2 expression levels.(Within one year)
- HER2 IHC score of histopathological(Within one year)
- Positive lymph node number of the histopathological(Within one year)
- ER percentage by different HER2 expression levels.(Within one year)
- Histological grade of histopathological(Within one year)
- PR percentage by different HER2 expression levels.(Within one year)
- FISH status of histopathological(Within one year)
- Pathological type of histopathological(Within one year)
- Multi-focal of histopathological(Within one year)
- PR status of histopathological(Within one year)
- The concordance between historical scoring and reassess scoring in each IHC score category (IHC score Ø, 1+, 2+and 3+)(Within one year)
- The concordance of HER2 expression between manual and AI assisted HER2 interpretation(Within one year)
- The concordance of HER2 expression between leading site (FUSCC) and other centers(Within one year)