Cervical CancersHERGYNNCT06925113
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
An observational study of Cervical Cancers and Endometrial Cancer, run by Daiichi Sankyo at 5 sites in Taiwan.
Trial 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 breast cancer, HER2-mutated lung cancer, HER2-positive gastric cancer, and HER2-low breast cancer in Taiwan. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancers, Endometrial Cancer, Ovarian Cancer
- How many people
- 509 participants
- Where
- 5 sitesTaiwan
- Study dates
- 31 Jan 2025to 26 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Taichung Veterans General Hospital
Taichung, 407
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 104
Taipei Veterans General Hospital
Taipei, 112
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Cervical Cancers, Endometrial Cancer, Ovarian Cancer
- Keywords
- gynecology, HER2 IHC, prevalence, Taiwan, retrospective
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent or advanced gynecologic cancers | Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer diagnosed between 2022 to 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand the prevalence rate of HER2 IHC 3+ in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan
Measured: from Jan 2022 to Dec 2024
Secondary outcomes (1)
To understand the prevalence rate of HER2 IHC 2+, 1+, and 0 in recurrent advanced endometrial cancer, ovarian cancer, and cervical cancer in Taiwan
Measured: from Jan 2022 to Dec 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start31 Jan 2025
- Primary completion31 Aug 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925113
- Sponsor's protocol ID
- DS8201-TWMA-Gyn-4001
- Acronym
- HERGYN
- Status last verified
- Nov 2025
- First submitted
- 6 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06925113
- Acronym / sponsor ID
- HERGYN / DS8201-TWMA-Gyn-4001
- Conditions
- Cervical Cancers, Endometrial Cancer, Ovarian Cancer
- Keywords
- gynecology, HER2 IHC, prevalence, Taiwan, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent or advanced gynecologic cancers | – | –Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer diagnosed between 2022 to 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent or advanced endometrial cancer, ovarian cancer, or cervical cancer
Key inclusion criteria (5 listed)
- Adults aged ≥ 18 years when their clinical data are reviewed
- Patients who fulfill ONE of the following criteria
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancers and Endometrial Cancer, run by Daiichi Sankyo at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.