NCT07617025 Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer
| NCT ID | NCT07617025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Angela Toss |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-09-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an observational study being carried out in several hospitals. No extra tests or procedures are required beyond those already part of normal medical care. The study is sponsored by the University of Modena and Reggio Emilia and aims to include about 100 patients. The main goal of the study is to better understand the different biological types of breast cancer in patients who have hormone receptor-positive (HR-positive), HER2-negative breast cancer related to BRCA gene mutations. In particular, the study will explore whether these cancers tend to belong to molecular types that may respond less to endocrine or CDK4/6 inhibitor therapy. The study also compares cancers linked to BRCA1 and BRCA2 mutations and investigates whether the different biological types are associated with differences in disease outcomes and response to treatment.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07617025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07617025 currently recruiting?
Yes, NCT07617025 is actively recruiting participants. Visit ClinicalTrials.gov or contact Angela Toss to inquire about joining.
Where is the NCT07617025 trial being conducted?
This trial is being conducted at Genova, Italy, Milan, Italy, Milan, Italy, Modena, Italy and 2 additional locations.
Who is sponsoring the NCT07617025 clinical trial?
NCT07617025 is sponsored by Angela Toss. The trial plans to enroll 100 participants.
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