Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease

• Establishment of a specimen bank [ Designated as safety issue: No ]
• Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results [ Designated as safety issue: No ]
• Ability of the qRT-PCR to predict treatment response [ Designated as safety issue: No ]
• Ability of the qRT-PCR to predict relapse [ Designated as safety issue: No ]
• Ability of the qRT-PCR to perform as an independent prognostic factor [ Designated as safety issue: No ]

RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.

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.

• Genetic: gene expression analysis
• Genetic: mutation analysis
• Genetic: proteomic profiling
• Genetic: reverse transcriptase-polymerase chain reaction
• Other: fluorescent antibody technique
• Other: immunohistochemistry staining method
• Other: laboratory biomarker analysis
• Other: liquid chromatography
• Other: mass spectrometry
• Other: medical chart review
• Procedure: quality-of-life assessment

DISEASE CHARACTERISTICS:

• Biopsy-confirmed diagnosis of one of the following:

  • Stage I-IV infiltrating ductal or infiltrating lobular carcinoma

    • Patients with early-stage disease must not have started systemic treatment; if no systemic treatment is planned, patients must be either preoperative or ≤ 120 days since definitive breast surgery
    • Patients with locally advanced disease must be scheduled for neoadjuvant chemotherapy prior to initiation of systemic treatment
  • Ductal carcinoma in situ
  • Lobular carcinoma in situ

  • Benign breast disease

    • Proliferative or non-proliferative
    • With or without atypia

PATIENT CHARACTERISTICS:

• Karnofsky performance status 50-100%
• Not pregnant
• No prior invasive cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage I-III disease