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