Status:
COMPLETED
A Study to Investigate the Prevalence of Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ and Characterize the Clinicopathologic Features of Gynecologic Cancers in Taiwan
Lead Sponsor:
Daiichi Sankyo
Conditions:
Cervical Cancers
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Trastuzumab Deruxtecan (T-DXd) is a humanized anti-HER2 monoclonal antibody covalently linked to DXd, which is a topoisomerase 1 inhibitor. T-DXd has been approved for the treatment of HER2-positive b...
Detailed Description
It is a non-interventional, multicenter, retrospective study to investigate the prevalence rate of HER2 IHC 3+ determined by IHC and characterize the clinicopathologic features of recurrent advanced e...
Eligibility Criteria
Inclusion
- Adults aged ≥ 18 years when their clinical data are reviewed
- Patients who fulfill ONE of the following criteria
- Imaging or histological diagnosis of recurrent advanced endometrial cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided)
- Imaging or histological diagnosis of recurrent advanced ovarian cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided)
- Imaging or histological diagnosis of recurrent advanced cervical cancer during 2022 to 2024, AND have tissue samples from recurrent advanced tumor (regardless of lines of received treatment) during 2022 to 2024 for HER2 IHC test (most recent and qualified pre-enrollment tumor sample must be provided)
Exclusion
- Without FFPE tumor sample from recurrent advanced tumors (specimens with limited tumor content and fine needle aspirates are inadequate for defining tumor HER2 status)
- With the retrospective nature and the use of anonymous clinical data, IRB/IEC/EC may grant permission to waive informed consent in this study. If the informed consent is not waived, patients or representatives who are not willing to provide written informed consent cannot be enrolled.
Key Trial Info
Start Date :
January 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 26 2025
Estimated Enrollment :
509 Patients enrolled
Trial Details
Trial ID
NCT06925113
Start Date
January 31 2025
End Date
September 26 2025
Last Update
November 17 2025
Active Locations (5)
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1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407
3
National Taiwan University Hospital
Taipei, Taiwan, 100
4
Mackay Memorial Hospital
Taipei, Taiwan, 104