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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898508
• Other study ID #: 04125
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Start date: August 2005
• Est. completion date: June 6, 2019

Study information

• Verified date: December 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Breast Neoplasms
• Carcinoma in Situ

Intervention

Genetic:
• gene expression analysis

• mutation analysis

• proteomic profiling

• reverse transcriptase-polymerase chain reaction

Other:
• fluorescent antibody technique

• immunohistochemistry staining method

• laboratory biomarker analysis

• liquid chromatography

• mass spectrometry

• medical chart review

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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