Clinical Research Directory

Carolina Breast Cancer Study Phase 4

Sponsor: UNC Lineberger Comprehensive Cancer Center

Summary

The Carolina Breast Cancer Study, Phase 4 (CBCS4) is a prospective, single-arm observational study examining interactions between tumor biology, health access, and patient behavior study. CBCS4 builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, and patient engagement must also be evaluated. Participants will complete a structured, in-person baseline interview covering breast cancer risk factors, quality of life, comorbidities, and initial treatment. Blood and/or saliva samples will be collected. Participants will provide consent for medical record abstraction and retrieval of tumor blocks. Medical record abstraction will be performed to confirm diagnoses through pathology reports and to collect clinical data, including TNM stage, ER/PR/HER2 status, and treatment history. Diagnostic tissue blocks will be requested from referring pathologists. Blood or saliva samples will be collected for DNA extraction, storage, and genotyping of breast cancer susceptibility genes. Tumor tissue blocks will be used for tissue microarray (TMA) construction, with up to nine cores obtained from each specimen. Central pathology review will be conducted to confirm diagnoses through evaluation of H\&E slides. TMAs will be analyzed by immunohistochemistry (IHC) to classify tumors into molecular subtypes, and a subset of samples will undergo RNA-based qtrs.-PCR for molecular subtype validation. Participants will be recontacted every 9 to 12 months for up to 10 years to update medical history, treatment information, and patient-reported outcomes. Longitudinal follow-up data will be used to assess treatment disparities, particularly among patients with aggressive tumor subtypes, evaluate quality of life and barriers to care using validated assessment tools, and support survivorship through the provision of educational updates and care navigation resources

Official title: Population-Based Molecular Epidemiology of Breast Cancer, Carolina Breast Cancer Study, Phase 4

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