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Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer

ClinicalTrials.gov IDNCT07617025

PhaseNot Applicable

Enrollment100

SponsorAngela Toss

Age18 Years

SexALL

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Conditions studied

Breast Cancer

About this study

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.

Primary outcomes

Distribution of intrinsic subtypes in BRCA1 and BRCA2-associated HR+/HER2-negative tumors (through study completion)
Overall survival depending on intrinsic subtype (through study completion)

Eligibility information

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

Study locations

Ospedale San Martino di Genova, Genova, 16132 Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milan, 20133 Italy
Istituto Oncologico Europeo di Milano, Milan, 20141 Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, 41124 Italy
Istituto Oncologico Veneto IRCCS Padova, Padova, 35128 Italy
Fondazione Policlinico Universitario Agostino Gemelli di Roma, Roma, 00168 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.