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 (HERGYN)

November 14, 2025 updated by: Daiichi Sankyo

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

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 breast cancer, HER2-mutated lung cancer, HER2-positive gastric cancer, and HER2-low breast cancer in Taiwan. Aside from clinical benefits in the above cancers, the DESTINY-PanTumor02 (NCT04482309) Phase II trial showed that T-DXd continued to demonstrate clinically meaningful and durable responses and survival benefits in previously treated patients across multiple HER2-expressing advanced solid tumors.

Among multiple types of solid tumors in the DESTINY-PanTumor02 trial, T-DXd showed a high confirmed objective response rate in heavily treated HER2 IHC 3+ endometrial cancer (EC, 84.6%, 11/13), ovarian cancer (OC, 63.6%, 7/11), and cervical cancer (CC, 75%, 6/8).

Previous evidence showed that HER2-expressing gynecologic cancers have limited treatment options and have poor prognoses under standard therapies. Data from DESTINY-PanTumor02 therefore serve as supporting evidence for T-DXd to become a potential therapeutic option for these HER2-expressing gynecologic cancers.

In August 2023, T-DXd received the FDA-designated breakthrough therapy designations and was approved in April 2024 for treating unresectable and metastatic HER2 IHC 3+ solid tumors that have progressed after prior treatment or lack satisfactory alternative options. The National Comprehensive Cancer Network (NCCN) has included T-DXd as a treatment option for HER2-positive endometrial, ovarian, and cervical carcinomas in their guidelines as of V1 2024.

However, the prevalence rate of HER2 IHC 3+ in recurrent advanced endometrial, ovarian, and cervical cancers in Taiwan remains unclear. Limited information is available regarding the HER2 amplification rate by ISH for specific cancer types.

In this retrospective, non-interventional study, the investigators aim to explore the prevalence of HER2 IHC 3+ in recurrent advanced endometrial, ovarian, and cervical cancers in Taiwan. The clinicopathologic characteristics will also be described, using information abstracted from the medical charts, to better understand and characterize the patient profiles of recurrent advanced endometrial, ovarian, and cervical cancers in Taiwan.

Study Overview

Status

Completed

Conditions

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 endometrial, ovarian, and cervical cancers in Taiwan. The study plans to include approximately 170 patients with endometrial cancer, 170 patients with ovarian cancer, and 170 patients with cervical cancer from five hospitals in Taiwan.

The study will retrospectively review medical charts to screen potential patients for enrollment in the study. A pathologist investigator meeting aligned with ASCO/CAP guidelines for scoring HER2 in Gastroesophageal Adenocarcinoma will be held to ensure the concordance of IHC scoring among different sites before patient enrollment.

Once enrolled, the study will collect the most recent and qualified archived tissue samples from recurrent advanced tumors of eligible patients to perform HER2 IHC test using Ventana 4B5 assay by pathologists per standard operational procedures at each hospital (after pathologist investigator meeting). If the patient already had HER2 IHC slides stained with Ventana 4B5 assay from recurrent advanced tumors, the pathologist will rescore the HER2 IHC data without conducting HER2 IHC staining again.

For patients who have archived primary tumor tissue samples before recurrence (2024 or before, regardless of FIGO stage), the study will also collect the primary tumor tissue samples before recurrence, which are qualified and sufficient for performing HER2 IHC test using Ventana 4B5 assay by pathologists per standard operational procedures at each hospital to analyze the changes in HER2 status after recurrence. If the patient already had HER2 IHC slides stained with Ventana 4B5 assay from the primary tumors before recurrence, the pathologist will rescore the HER2 IHC data without conducting HER2 IHC staining again.

In addition to the HER2 IHC test, patient-level data, including demographics, clinicopathologic characteristics, standard and exploratory diagnostic information (e.g., histopathology and biomarkers), and the clinical presentation of gynecologic cancers (e.g., FIGO stage, metastatic sites, etc.) will be abstracted from medical charts of enrolled patients after de-identification.

Study Type

Observational

Enrollment (Actual)

509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer

Description

Inclusion Criteria:

  1. Adults aged ≥ 18 years when their clinical data are reviewed

  2. 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 Criteria:

  1. Without FFPE tumor sample from recurrent advanced tumors (specimens with limited tumor content and fine needle aspirates are inadequate for defining tumor HER2 status)
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Recurrent or advanced gynecologic cancers
Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer diagnosed between 2022 to 2024

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To understand the prevalence rate of HER2 IHC 3+ in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan
Time Frame: from Jan 2022 to Dec 2024
from Jan 2022 to Dec 2024

Secondary Outcome Measures

Outcome Measure
Time Frame
To understand the prevalence rate of HER2 IHC 2+, 1+, and 0 in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan
Time Frame: from Jan 2022 to Dec 2024
from Jan 2022 to Dec 2024

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the correlation between HER2 IHC status and other biomarkers in gynecologic cancers by correlation coefficient analysis
Time Frame: from Jan 2022 to Dec 2024
from Jan 2022 to Dec 2024
To assess changes in HER2 IHC score between primary tumor before recurrence and recurrent advanced tumor
Time Frame: from Jan 2022 to Dec 2024
To assess changes in HER2 IHC score between primary tumor before recurrence and recurrent advanced tumor by calculating the changes in HER2 IHC score (HER2 IHC score is categorized into 0, 1+, 2+, and 3+)
from Jan 2022 to Dec 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Investigators

  • Study Director: Annie Yang, Daiichi Sankyo Taiwan Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-TWMA-Gyn-4001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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