Clinical trial NCT00898508: Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease
Official title: Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 563
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: City of Hope New patients

Brief 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 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

Primary outcomes:
measure: Establishment of a specimen bank
timeFrame: 5 Years of specimen collection
measure: Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
timeFrame: 5 years
measure: Ability of the qRT-PCR to predict treatment response
timeFrame: 5 years
measure: Ability of the qRT-PCR to predict relapse
timeFrame: 5 years
measure: Ability of the qRT-PCR to perform as an independent prognostic factor
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Pasadena
country: United States
facility: City of Hope Medical Group
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Robert Hickey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: