Patient case: 54-year-old female with Breast cancer. Genetic variant: PTEN Loss. Other conditions: Congestive Heart Failure.

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

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.

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.

Eligibility: 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

Relevance to patient case: definitely relevant