HER2 expression across Brazilian gynecologic cancers
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
AstraZeneca · NCT07101081
This will test HER2 protein levels in tumor samples from adults with gynecologic cancers treated at Oncoclínicas sites to see how often HER2 is highly expressed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Sex | Female |
| Sponsor | AstraZeneca (industry) |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT07101081 on ClinicalTrials.gov |
What this trial studies
This is a retrospective molecular epidemiology project that uses archived primary tumor paraffin blocks collected from adults diagnosed with gynecologic cancers between January 2020 and March 2025. Partner pathology labs in the OC Precision Medicine network will send slides to Locus Lab (São Paulo) for automated HER2 immunohistochemistry using Dako HercepTest and Roche Ventana 4B5. HER2 staining will be scored using multiple criteria (gastric, breast, and endometrial cancer scoring systems) to report rates of high expression (IHC 3+ by Dako/gastric criteria). The primary focus is prevalence in endometrial, ovarian, and cervical cancers, with secondary description for vulvar and vaginal cancers.
Who should consider this trial
Good fit: Adults (≥18 years) diagnosed with endometrial, ovarian/peritoneum/uterine tube, cervical, vulvar, or vaginal cancer between January 2020 and March 2025 who have sufficient primary tumor paraffin tissue and provide consent (or have a consent waiver).
Not a fit: Patients without adequate primary tumor tissue, those whose diagnosis was made on a metastatic lesion, or those who received systemic anticancer therapy before surgery/biopsy are not eligible and unlikely to benefit from inclusion.
Why it matters
Potential benefit: If successful, this could identify patients with HER2-high gynecologic tumors who might be eligible for HER2-targeted therapies or clinical trials.
How similar studies have performed: HER2 testing and HER2-targeted therapies are established in breast and gastric cancers and have shown benefit in some HER2-positive gynecologic subsets (for example uterine serous carcinoma), but broad prevalence data across all gynecologic cancers remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
São Paulo
- Research Site — São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Angélica Nogueira Rodrigues — Oncoclínicas Precision Medicine
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gynaecological Cancers, Gynaecological cancers, HER-2