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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07617025

Acronym

PAMBRACA

Enrollment

100

Registered

2026-06-01

Start date

2024-09-05

Completion date

2026-12-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, molecular characterization, Breast Cancer 360, CDK4/6 inhibitors, hormone receptor-positive, transcriptomic analysis, gene expression, BRCA1, BRCA2, germline

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Distribution of intrinsic subtypes in BRCA1 and BRCA2-associated HR+/HER2-negative tumors	through study completion	To evaluate the differences in intrinsic subtype distribution between BRCA1 and BRCA2-associated HR+/HER2-negative tumors.
Overall survival depending on intrinsic subtype	through study completion	To explore the prognostic role of different intrinsic subtypes in terms of overall survival (OS) in HR+/HER2-negative BRCA-associated breast cancer

Secondary

Measure	Time frame	Description
Benefit from CDK4/6 inhibitors depending on molecular subtype	through study completion	Evaluating sensitivity to CDK4/6 inhibitors and PARP inhibitors by molecular subtype in HR+/HER2-negative BRCA-related tumors.
Molecular features of BRCA1-related and BRCA2-related breast cancers	through study completion	To evaluate, through a multigene panel, the different molecular expression of HR+/HER2-negative BRCA1-related and BRCA2-related breast cancers.

Countries

Italy

Outcome results