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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer, HER2

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

• Study Type: Observational
• Enrollment (Actual): 3136

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Research Site
  • Jinan, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Wuhan, China
    • Research Site
  • Xi'an, China
    • Research Site
  • Zhengzhou, China
    • Research Site
  • Shanhai
    • Shanghai, Shanhai, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of HER2 IHC0 and HER2 IHC >0<1+	To estimate the prevalence of HER2 IHC0 and HER2 IHC >0<1+ in PART 2	Within one year
Age at diagnosis of patients' demographic at baseline	Age at diagnosis of patients' demographic at baseline by different HER2 expression level in PART 1	At baseline
BMI of patients' demographic at baseline	BMI of patients' demographic at baseline by different HER2 expression level in PART 1	At baseline
Menopause or not of patients' demographic at baseline	Menopause or not of patients' demographic at baseline by different HER2 expression level in PART 1	At baseline
The baseline treatment patterns across patients with different HER2 expression levels	Patients' treatment patterns at baseline, by different HER2 expression level in PART 1	At baseline

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Wentao Yang, Dr., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer,HER2
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D9673R00011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No