Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
NCT ID: NCT00898508
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
563 participants
OBSERVATIONAL
2005-08-31
2019-06-06
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal benign breast disease or ductal carcinoma in situ
gene expression analysis
mutation analysis
proteomic profiling
reverse transcriptase-polymerase chain reaction
fluorescent antibody technique
immunohistochemistry staining method
laboratory biomarker analysis
liquid chromatography
mass spectrometry
medical chart review
quality-of-life assessment
Invasive breast cancer
gene expression analysis
mutation analysis
proteomic profiling
reverse transcriptase-polymerase chain reaction
fluorescent antibody technique
laboratory biomarker analysis
liquid chromatography
mass spectrometry
medical chart review
quality-of-life assessment
Interventions
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gene expression analysis
mutation analysis
proteomic profiling
reverse transcriptase-polymerase chain reaction
fluorescent antibody technique
immunohistochemistry staining method
laboratory biomarker analysis
liquid chromatography
mass spectrometry
medical chart review
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Robert Hickey, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Countries
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Other Identifiers
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CHNMC-04125
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000628766
Identifier Type: REGISTRY
Identifier Source: secondary_id
04125
Identifier Type: -
Identifier Source: org_study_id
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