Predicting Breast Cancer Subtypes in BRCA-Associated HR+/HER2-Negative Disease
Official title: Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer
Run by University of Modena and Reggio Emilia · NCT07617025 · Data updated 2026-11-12
This study tests whether BRCA1/BRCA2-related, hormone-receptor–positive, HER2-negative breast cancers have distinct molecular subtypes that might respond differently to endocrine therapy or CDK4/6 inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 6 sites (Genova and 5 other locations) |
| Status | Recruiting |
| Started | September 5, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07617025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with BRCA1 or BRCA2 pathogenic variants and HR+/HER2-negative breast cancer who have available medical records and FFPE tumor tissue.
✕Probably not a fit
Patients without BRCA mutations or those lacking available tumor tissue or records may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects existing clinical data and tissue samples from about 100 patients across several Italian hospitals. It aims to characterize intrinsic molecular subtypes of BRCA-associated HR+/HER2-negative breast cancer and see if these subtypes relate to treatment response and outcomes. No additional procedures beyond standard care are required, and FFPE tumor tissue is used for molecular analysis. The study compares cancers arising from BRCA1 versus BRCA2 mutations to explore potential differences in biology and prognosis.
Why it matters
Potential benefit: Understanding molecular subtypes could help tailor treatment choices and predict outcomes for BRCA-associated HR+/HER2-negative breast cancer.
How similar studies have gone: Previous studies suggest molecular subtypes influence response to therapy in BRCA-related cancers, but this study builds on that by focusing on HR+/HER2-negative cases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Patients carrying a pathogenic or likely pathogenic germline variant in BRCA1 or BRCA2 with a histologically confirmed diagnosis of HR+/HER2-negative breast cancer * Patients with available hospital and/or outpatient medical records for clinical data collection * Presence of available formally fixed paraffin-embedded (FFPE) breast tumor tissue (primary or metastatic site) Exclusion Criteria: * None
Where it's running
-
Ospedale San Martino di Genova
Genova, Italy Recruiting -
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Milan, Italy Recruiting -
Istituto Oncologico Europeo di Milano
Milan, Italy Recruiting -
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy Recruiting -
Istituto Oncologico Veneto IRCCS Padova
Padova, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli di Roma
Roma, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.