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Clinical Trial Summary

This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.

Clinical Trial Description

The study will involve patients diagnosed with HER2-positive unresectable or mBC since 01 January 2017 and who received at least 2 LOTs. The data will be collected retrospectively from the date of diagnosis of unresectable or mBC (index date) to the end of follow-up (ie, until death, the last medical record entry, or date of data extraction, whichever is earlier). The study will not have any study-specific patient visits or a longitudinal follow-up. All available data will be extracted from patients' medical records after obtaining an informed consent at one time. The informed consent may be obtained at the time of patients routine clinical care visit to the oncology centre. The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics will be extracted from patients medical records. The study will be implemented at approximately 80 to 100 oncology centres spanning across 7 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries). Two cohorts are planned to account for different study timelines. Cohort 1 will include all patients recruited outside China, including Australia, Brazil, Singapore, Taiwan, Korea, and Hong Kong special administrative region (SAR) (approximately 780 patients), and Cohort 2 will include patients from all countries including China (approximately 1280 patients). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04857619
Study type Observational
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Not yet recruiting
Start date April 30, 2021
Completion date June 30, 2022

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