Breast Duct Lavage, Breast Duct Endoscopy, and Gene Expression Profiling in Women With Breast Cancer Compared With Healthy Women Who Are and Are Not at High Risk for Breast Cancer - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00070460

Purpose

RATIONALE: Diagnostic procedures, such as breast duct lavage and breast duct endoscopy, may help doctors find tumor cells early and plan better treatment for breast cancer. Studying the pattern of gene expression in breast duct cells from patients with breast cancer and from healthy participants may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying breast duct lavage, breast duct endoscopy, and gene expression profiling to look for changes in breast duct cells in women with breast cancer compared with healthy women who are and are not at high risk for breast cancer.

Condition	Intervention
Breast Cancer	Genetic: comparative genomic hybridization Genetic: microarray analysis Genetic: proteomic profiling Other: cytology specimen collection procedure Procedure: breast duct lavage Procedure: breast imaging study Procedure: endoscopic biopsy

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Characterization Of High Risk Breast Duct Epithelium By Cytology, Breast Duct Endoscopy, And cDNA Gene Expression Profile

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	110
Study Start Date:	January 2002

Detailed Description:

OBJECTIVES:

Primary

Compare the incidence and nature of cytologic changes in women with ipsilateral breast cancer vs healthy women who are and are not at increased risk for breast cancer using breast duct lavage.
Characterize high-risk contralateral breast ductal epithelium and architecture in these women using breast duct endoscopy and correlate these findings with the incidence of cytologic changes.
Compare the global gene expression pattern in these participants.

Secondary

Determine the effects of estrogen replacement therapy on cytology and the gene expression profile of normal ductal epithelial cells in postmenopausal women by examining normal epithelial cells before and after initiation of estrogen replacement therapy.
Determine the gross genomic alterations present in high risk breast epithelial cells by comparative genomic hybridization in patients with ipsilateral breast cancer.
Determine the pattern of protein expression for selected proteins in the high-risk epithelial cells using proteomics tissue lysate arrays in these patients.

OUTLINE: Participants are stratified according to menopausal status (premenopausal vs postmenopausal).

Participants undergo breast duct lavage (in the contralateral breast for breast cancer patients and in either normal breast for healthy volunteers and high-risk subjects) and breast duct endoscopy.

Participants found to have cytologic atypia may undergo MRI and/or galactography to further localize or excise the abnormality. Participants with a cytologic atypia not suspected for malignancy undergo a follow-up lavage and endoscopy in 3-6 months.

Gene expression profiles, comparative genomic hybridization, and proteomic profiles are conducted on lavage cells.

PROJECTED ACCRUAL: A total of 110 participants (70 breast cancer patients and high-risk subjects [35 per stratum] and 40 healthy volunteers [20 per stratum]) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Breast cancer and high-risk subjects

Diagnosis of unilateral breast cancer of epithelial origin (breast cancer patients)
- Invasive or noninvasive
- Cytologic or histologic evidence of ductal hyperplasia, atypical ductal hyperplasia, or lobular carcinoma in situ
No breast cancer but Gail Index greater than 1.67% (high-risk subjects)
Contralateral breast must be free of any suspicious areas by physical examination and mammogram AND without prior invasive ductal carcinoma or ductal carcinoma in situ
- Prior atypia or lobular carcinoma in situ on biopsy is allowed
BRCA ½ mutation carriers
No contralateral breast prosthesis (breast cancer patients)
No bilateral breast prosthesis (high-risk subjects)
No prior contralateral major duct excision (breast cancer patients)
No prior bilateral major duct excision (high-risk subjects)
No lactating breast

Healthy volunteers

Gail model risk index less than 1.67%
Both breasts must be free of any suspicious areas by physical examination and mammogram (a mammogram is required only for women over 30 years of age)
No prior atypical hyperplasia or invasive or in situ carcinoma
No prior bilateral major duct excision
No bilateral breast prosthesis
No lactating breasts

PATIENT CHARACTERISTICS:

Age

Adult

Sex

Female

Menopausal status

Premenopausal or postmenopausal
- Postmenopausal defined as the absence of menstrual periods for at least 24 months
- Postmenopausal women who have previously undergone a hysterectomy without oophorectomy must have a serum follicle-stimulating hormone greater than 40 IU/mL and a serum estradiol level of less than 40 pg/mL

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

WBC greater than 2,500/mm^3
Platelet count greater than 50,000/mm^3

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant
Negative pregnancy test
No concurrent infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 3 months since prior chemotherapy (breast cancer patients)

Endocrine therapy

See Disease Characteristics
No concurrent antiestrogen therapy
No concurrent hormone replacement therapy or oral contraceptives

Radiotherapy

No prior radiotherapy to the contralateral breast (breast cancer patients)
No prior therapeutic mediastinal radiotherapy (healthy volunteers or high-risk subjects)

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070460

Locations

United States, Maryland
NCI - Surgery Branch	Recruiting
Bethesda, Maryland, United States, 20892
Contact: David N. Danforth, MD, MS 301-496-1533 david_danforth@nih.gov
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Contact Person 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

David N. Danforth, MD, MS

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000334479, NCI-02-C-0077
Study First Received:	October 3, 2003
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00070460 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009