Status:
COMPLETED
Prevalence and Clinicopathologic Features of Different HER2 Level in Chinese Breast Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer, HER2
Eligibility:
All Genders
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...
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 yea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
3136 Patients enrolled
Trial Details
Trial ID
NCT05203458
Start Date
February 24 2022
End Date
July 5 2023
Last Update
May 16 2024
Active Locations (7)
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1
Research Site
Shanghai, Shanhai, China
2
Research Site
Guangzhou, China
3
Research Site
Jinan, China
4
Research Site
Shenyang, China