Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

Brief Summary

Detailed Description

OBJECTIVES: Primary * To establish a specimen bank from peripheral blood specimens collected from women with a full spectrum of breast disease (invasive breast cancer \[IBC\], ductal or lobular carcinoma in situ \[CIS\], or benign breast disease \[BBD\]) with standardized clinical follow up and serial specimen collection for those with IBC. * To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR) to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay values from pre-biopsy specimens to the histologic diagnosis. * To determine the ability of qRT-PCR to predict treatment response by comparing serial assay values from patients with evaluable IBC to their objective response. * To determine the ability of qRT-PCR to predict relapse by comparing the serial assay values from all patients with IBC to their disease status. * To determine the ability of qRT-PCR to perform as an independent prognostic factor by comparing baseline assay values from all patients with IBC to their disease status, stratified by known breast cancer prognostic factors. Secondary * To perform exploratory studies identifying potential targets for novel nucleic acid and proteomic-based early detection assays. OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via quantitative real-time reverse-transcriptase PCR, immunofluorescence, and bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass spectometry. Patients' tumor tissue (invasive breast cancer \[IBC\] only) is analyzed for p53 via IHC. Medical records are reviewed periodically. Patients with IBC complete a quality of life assessment at baseline and every 6 months for up to 10 years.

Primary Outcomes