Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Breast Cancer
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Retrospective
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
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 medica...
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).
Tracking Information
- NCT #
- NCT04857619
- Collaborators
- Parexel
- Investigators
- Not Provided