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NCT Number: NCT07617025

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Martino di Genova, Genova, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Distribution of intrinsic subtypes in BRCA1 and BRCA2-associated HR+/HER2-negative tumors

    Time frame: through study completion

    To evaluate the differences in intrinsic subtype distribution between BRCA1 and BRCA2-associated HR+/HER2-negative tumors.

  2. Overall survival depending on intrinsic subtype

    Time frame: 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 outcomes

  1. Benefit from CDK4/6 inhibitors depending on molecular subtype

    Time frame: through study completion

    Evaluating sensitivity to CDK4/6 inhibitors and PARP inhibitors by molecular subtype in HR+/HER2-negative BRCA-related tumors.

  2. Molecular features of BRCA1-related and BRCA2-related breast cancers

    Time frame: through study completion

    To evaluate, through a multigene panel, the different molecular expression of HR+/HER2-negative BRCA1-related and BRCA2-related breast cancers.

Sponsors and collaborators

Lead sponsor

Angela Toss

Other

Registry information

Acronym: PAMBRACA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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