studying blood and tumor tissue samples in women with invasive breast cancer, ductal or lobular carcinoma in situ, or benign breast disease

Conditions: Breast Cancer

Summary: 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.

Eligibility criteria:
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

Keywords: invasive ductal breast carcinoma invasive lobular breast carcinoma ductal breast carcinoma in situ lobular breast carcinoma in situ stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer