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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Genetic: gene expression analysis; Other: medical chart review; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: proteomic profiling; Other: mass spectrometry; Genetic: reverse transcriptase-polymerase chain reaction; Procedure: quality-of-life assessment; Other: immunohistochemistry staining method; Other: fluorescent antibody technique; Other: liquid chromatography

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.

• Study Type: Observational
• Enrollment (Actual): 563

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Tower Cancer Research Foundation
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • Pasadena, California, United States, 91105
      • City of Hope Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

City of Hope New patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal benign breast disease or ductal carcinoma in situ	Genetic: gene expression analysis; Other: medical chart review; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: proteomic profiling; Other: mass spectrometry; Genetic: reverse transcriptase-polymerase chain reaction; Procedure: quality-of-life assessment; Other: immunohistochemistry staining method; Other: fluorescent antibody technique; Other: liquid chromatography
Invasive breast cancer	Genetic: gene expression analysis; Other: medical chart review; Other: laboratory biomarker analysis; Genetic: mutation analysis; Genetic: proteomic profiling; Other: mass spectrometry; Genetic: reverse transcriptase-polymerase chain reaction; Procedure: quality-of-life assessment; Other: fluorescent antibody technique; Other: liquid chromatography

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert Hickey, Ph.D., City of Hope Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimated): May 12, 2009

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer; ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; lobular breast carcinoma in situ
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Carcinoma; Breast Neoplasms; Carcinoma in Situ; Breast Diseases; Immunologic Factors; Physiological Effects of Drugs; Antibodies
• Other Study ID Numbers: 04125; P30CA033572 (U.S. NIH Grant/Contract); CHNMC-04125 (Registry Identifier: NCI PDQ); CDR0000628766 (Registry Identifier: NCI)