GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort

NCT07101081 | Recruiting

• 1 other identifier: D9673R00061
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients with gynecologic cancer (endometrial, ovarian, cervical, vulvar and vaginal cancers) treated at Oncoclínicas \& CO sites will be enrolled for primary tumor immunohistochemistry (IHC) analysis. When sufficient paraffin tissue is available for biomarker testing, slides will be sent from partner Pathology Labs of the OC Precision Medicine network to Locus Lab (São Paulo) for HER2 staining with automated protocols (Dako HercepTest and Roche Ventana 4B5) and scoring using different criteria (gastric cancer, breast cancer, and endometrial cancer). Primary objective is to describe the prevalence of HER2 high expression (IHC 3+ using Dako HercepTest and gastric cancer scoring criteria) in endometrial, ovarian, and cervical cancers (common gynecological malignancies). Secondary objectives are to describe the prevalence of HER2 high expression (IHC 3+ using Dako HercepTest and gastric cancer scoring criteria) in vulvar and vaginal cancers (rare gynecological malignancies); and to describe the prevalence of different HER2 expression levels (IHC 0, 1+ and 2+ using Dako HercepTest and gastric cancer scoring criteria) across all gynecological malignancies, to describe HER2 expression levels as per endometrial cancer scoring criteria in the endometrial cohort; to describe the association of different histological subtypes of gynecological cancer with HER2 IHC expression levels.

Conditions

Gynaecological Cancers

Keywords

Gynaecological cancers; HER-2

Outcome Measures

Primary Outcomes (1)

• HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.

  To describe the prevalence of HER2 high expression (IHC 3+) in a cohort of patients in Brazil with gynecological cancers (cervical, endometrial and ovarian cancers).

  Through study completation,an average of 1 year

Secondary Outcomes (1)

• HER2 IHC status as per Dako HercepTest and gastric cancer scoring criteria.

  Through study completation,an average of 1 year

Interventions

HER-2 Test DIAGNOSTIC_TEST

Samples from patients with gynecological tumors eligible to the study will be retrospectively identified and the paraffin slides will be sent to central laboratory to perform HER2 IHC testing using the automated protocols (Dako and Ventana). Expert pathologists will select primary tumor samples from surgery or excisional biopsies with enough material to perform HER2 testing using both antibodies without exhausting the cancer tissue. The entire cohort will be tested with both Dako HercepTest and Roche Ventana 4B5 antibody using gastric cancer and breast cancer criteria for positivity (3+, 2+ and 1+, 0).

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In total, 350 samples in total (100 cervical cancer, 100 endometrial cancer, 100 ovarian cancer, and 50 vulvar or vaginal cancer).

You may qualify if:

• Age \>= 18 years at sample collection; - Diagnosis of cervical, endometrial, ovarian/peritoneum/uterine tube, vulvar, or vaginal cancers;
• Sufficient paraffin primary tumor tissue for biomarker testing in the OC Precision Medicine Pathology labs.
• Date of diagnosis of gynecological cancer must be from January 2020 to March 2025.
• Patients need to sign informed consent, or waiver of informed consent is granted.

You may not qualify if:

• Patients without sufficient paraffin tissue for the proposed biomarker testing.
• Patients whose diagnosis was performed in metastatic lesion.
• Patients with history of exposure to systemic anti-cancer therapies for the gynecological cancer diagnosis before surgery or excisional biopsy of gynecological cancer (information is available in the original histopathology request document stored in the LIMS).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

São Paulo, Brazil

RECRUITING

Study Officials

• Angélica Nogueira Rodrigues

  Oncoclínicas Precision Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 3, 2025
• Study Start: April 23, 2026
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (1)