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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:20 - Any
Updated:12/21/2018
Start Date:August 2005
End Date:November 2020

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Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

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
We found this trial at
3
sites
1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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Beverly Hills, California 90211
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Pasadena, California 91105
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