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

NCT05203458

CompletedN/A

Sponsor: AstraZeneca

Conditions: Breast Cancer, HER2

Countries: China

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

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (7)

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