Trial record 9 of 19 for:    breast cancer AND premenopausal | Open Studies | United States

High-Risk Breast Duct Epithelium

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00028340
First received: December 21, 2001
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

Background:

Breast cancer is the most common malignancy in women, occurring in over 180,000 women annually in the United States.

The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood, however several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ.

The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment.

Objectives:

The primary objectives are:

To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high risk breast, in specimens collected by breast duct lavage, and to determine if these cytologic findings are different from those of normal women not at increased risk for breast cancer.

To characterize by breast duct endoscopy, high risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings from above.

To determine what is the global gene expression pattern of high risk breast epithelial cells from the high risk breast, and does this differ from that of breast epithelial cells from normal women not at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR.

To determine by comparative genomic hybridization the gross genomic alterations present in high risk breast epithelial cells.

To determine the pattern of protein expression for selected proteins in the high risk epithelial cells using proteomics tissue lysate arrays.

To examine ductal epithelial cell preparations from both normal risk and high risk women for the presence of mammary stem cells.

Eligibility:

Eligibility for high risk individuals will include:

Women of any age with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.

Women without breast cancer, but with a Gail Index greater than 1.67%.

Women known to be BRCA1/2 mutation carriers.

Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.

Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 24 months.

Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.

Eligibility for normal volunteers will include:

Women who are premenopausal or postmenopausal with a Gail model risk index Less than 1.67%.

Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.

Both breasts must be free of any suspicious areas by physical examination and mammogram, and no past history of atypical hyperplasia, invasive or in situ carcinoma.

Both groups must have acceptable WBC and platelet counts.

Design:

Breast ductal epithelial cells will be collected by breast duct lavage from a.) the breast in women at increased risk for breast cancer, and b.) the breast of female normal volunteers who are not at increased risk for breast cancer.

Ductal epithelial cell specimens will be analyzed cytologically for the presence of hyperplasia, atypia, or in situ changes.

Breast duct endoscopy will be performed in breast cancer patients and in normal volunteers to determine ductal architectural changes associated with increased risk for breast cancer, and to provide correlation with cytologic studies.

The gene expression profile of normal and high risk ductal epithelial cells will be studied by cDNA microarray to determine changes in gene expression associated with increased risk for breast cancer.

Additional molecular profiling experiments which will be performed as lavage cells are available include Comparative Genomic Hybridization (CGH), proteomic tissue lysate arrays, and identification of mammary stem cells.

A total of 70 breast cancer patients and 40 normal volunteers will be studied, divided approximately evenly between premenopausal and postmenopausal women. After accruing the first 20 individuals for a given menstrual status, an analysis will be performed. If more than 5 patients yield less than or equal to 7000 ductal cells/lavage, then the trial will be re-evaluated prior to proceeding with additional enrollment....


Condition
Breast Neoplasms
Healthy

Study Type: Observational
Official Title: Characterization of High Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 155
Study Start Date: December 2001
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Breast Cancer and High Risk Patients:

Women of any age with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin.

Women without breast cancer, but with a Gail Index greater than 1.67%.

Women known to be BRCA1/2 mutation carriers.

Women with cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ.

Women may be either premenopausal or postmenopausal. Postmenopausal is defined by the absence of menstrual periods for at least 24 months.

Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.

Breast cancer may be invasive or noninvasive, and in the past or the present.

The contralateral breast of women with breast cancer, or the normal breast of high risk subjects, must be free of any suspicious areas by physical examination and mammogram, and without past history of invasive ductal or in situ ductal carcinoma. A past history of atypia or LCIS on a previous biopsy is acceptable.

Women who are from a family with heritable breast cancer with a known deleterious BRCA1/2 mutation, who themselves have been tested and to not carry this mutation. These women are not at increased risk for breast cancer due to the familial mutation and are eligible to participate as normal volunteers.

WBC greater than 2500.

Platelets greater than 50,000.

Normal Volunteers

Women who are premenopausal or postmenopausal with a Gail model risk index less than 1.67%.

Women who have previously undergone a hysterectomy without oophorectomy must have a serum FSH level of greater than 40 IU/ml, and a serum estradiol level of less than 40 pg/ml to document postmenopausal status.

Both breasts must be free of any suspicious areas by physical examination and, for women over 30 years of age by mammogram. There must be no past history of atypical hyperplasia, invasive or in situ carcinoma.

WBC greater than 2500.

Platelets greater than 50,000.

EXCLUSION CRITERIA:

Breast Cancer Patients:

Contralateral breast prosthesis.

Pregnancy.

History of radiation therapy to the contralateral breast.

Lactating breast.

Chemotherapy within the past 1 month.

Current antiestrogen therapy.

Current hormonal replacement therapy or oral contraceptives.

Concurrent infection.

Previous contralateral major duct excision.

High Risk Subjects

Bilateral breast prosthesis.

Pregnancy.

Lactating breast.

Current antiestrogen therapy.

Current hormonal replacement therapy or oral contraceptives.

Concurrent infection.

Previous bilateral major duct excision.

History of therapeutic mediastinal radiation.

Normal Volunteers

Bilateral breast prosthesis.

Pregnancy.

Lactating breast.

Current antiestrogen therapy.

Current hormonal replacement therapy or oral contraceptives.

Concurrent infection.

Previous bilateral major duct excision.

History of therapeutic mediastinal radiation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028340

Contacts
Contact: David N Danforth, M.D. (301) 496-1533 danforth@pop.nci.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: David N Danforth, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00028340     History of Changes
Obsolete Identifiers: NCT00070460
Other Study ID Numbers: 020077, 02-C-0077
Study First Received: December 21, 2001
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Breast Cancer
Breast Duct
Molecular Profiling
Proteomic Tissue
Lysate Arrays
Ductal Changes
Effects of Estrogen
Comparative Genomic Hybridization
Post Menopausal
Healthy Volunteer
HV
Normal Control

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014