| Company Name | Daiichi Sankyo Taiwan Ltd. |
|---|---|
| Protocol Number | DS8201-TWMA-Gyn-4001 |
| Title of Study | A Retrospective, Non-interventional, Multicenter Study to Investigate the Prevalence of HER2 IHC 3+ and Characterize the Clinicopathologic Features of Gynecologic Cancers in Taiwan –The HERGYN Study |
| Primary Objective | Primary objective: - To understand the prevalence rate of HER2 IHC 3+ in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan Secondary objective: - To understand the prevalence rate of HER2 IHC 2+, 1+, and 0 in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan Exploratory objective: 1. To assess changes in HER2 IHC status between primary tumor before recurrence and recurrent advanced tumor 2. To assess the correlation between HER2 IHC status and other biomarkers in gynecologic cancers |
| Number of Sites | 5 |
| Period of Study | From：November/30/2024 to：June/30/2026 |
| Number of Patients | 510人 |
| IRB Approval Date | National Taiwan University Hospital: October/14/2024 Kaohsiung Chang Gung Memorial Hospital: October/31/2024 |
| Publication Plan / Date | March/31/2027 |
