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.

Full Title of Study: “Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 6, 2019

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.


  • 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

Arms, Groups and Cohorts

  • Normal benign breast disease or ductal carcinoma in situ
  • Invasive breast cancer

Clinical Trial Outcome Measures

Primary Measures

  • Establishment of a specimen bank
    • Time Frame: 5 Years of specimen collection
  • Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
    • Time Frame: 5 years
  • Ability of the qRT-PCR to predict treatment response
    • Time Frame: 5 years
  • Ability of the qRT-PCR to predict relapse
    • Time Frame: 5 years
  • Ability of the qRT-PCR to perform as an independent prognostic factor
    • Time Frame: 5 years

Participating in This Clinical Trial


  • 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
  • Gender Eligibility: Female

    Minimum Age: 20 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • City of Hope Medical Center
    • Collaborator
      • National Cancer Institute (NCI)
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Robert Hickey, Ph.D., Principal Investigator, City of Hope Comprehensive Cancer Center

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