Protocol Number: 02-C-0077

Title:

Characterization of High Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile

Number:

02-C-0077

Summary:

This study will evaluate two potential new methods for detecting breast cancer: breast duct lavage and breast duct endoscopy. The procedures will be done in women at increased risk of breast cancer and in women at low risk of breast cancer, and the findings will be compared.

Women who have, or have had, breast cancer in one breast (and are therefore at increased risk of cancer in the second breast) and healthy, normal women volunteers at low risk for breast cancer may be eligible for this study. All participants must be postmenopausal-that is, they must have had their last menstrual period at least 24 months prior to entering the study. Candidates will be screened with a history and physical examination, blood tests and pregnancy test. Participants will undergo the following procedures:

Breast Duct Lavage

1. 30 minutes before this procedure, the participant massages her breast to help increase the number of cells that can be obtained during lavage.

2. The nipple is numbed with an anesthetic and a warm towel is placed over the breast.

3. Dead skin and body oils are removed from the nipple with a special lotion and the area is then cleaned with alcohol and gauze.

4. A breast pump is placed over the nipple and gentle suction is applied to bring out fluid. The fluid-containing milk ducts are identified by nipple discharge. (If no fluid is obtained, lavage cannot be performed and the procedure will end.)

5. If a duct is identified, the participant is given a sedative injected into an arm vein and a very slender tube (catheter) is threaded about 1 inch into the duct. A salt solution is injected into the duct through the catheter. The breast is gently massaged and gentle pressure is applied to draw out fluid.

The procedure is repeated on other milk ducts or to identify a duct. (In general, one or two ducts per breast yield fluid.) The catheter will be in each duct for several minutes. The entire procedure takes from 10 to 30 minutes.

Breast Duct Endoscopy

This procedure is done at the same time as breast duct lavage, also under a sedative. The duct that was used for the lavage is used for the endoscopy.

1. A duct at the nipple is gently enlarged with small metal wires, and the ductoscope (a small tube with a camera attached to examine the lining of the duct) is passed into the duct and then further into the breast.

2. Water may be injected through the scope into the duct to open the duct and make it easier to pass the scope.

3. Fluid may be collected through the scope and examined, as was done during lavage.

4. A very thin wire probe may be passed up to several inches into the breast to sample any abnormalities that might be found.

The ductoscopy findings are recorded on videotape. The procedure takes no more than 60 minutes.

Excess material obtained from the procedures will be used for genetic studies and stored for future research on breast cancer. Patients in whom pre-cancerous or cancerous cells are found will be contacted and may have additional studies, such as breast MRI or breast duct X-rays for further evaluation. Patients in whom breast cancer is found will be offered treatment and follow-up (generally for 5 years) at NIH.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria:

INCLUSION CRITERIA:

BREAST CANCER PATIENTS:

Women of any age with a unilateral invasive breast cancer of epithelial origin.

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 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.

WBC greater than 2500.

PT/PTT less than 1.5X normal.

Platelets greater than 50,000.

NORMAL VOLUNTEERS:

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

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.

Women who plan to initiate hormone replacement therapy (premarin + provera) within the next 3 months and who plan to continue that therapy for at least 3 months will also be eligible.

WBC greater than 2500.

PT/PTT less than 1.5X normal.

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 3 months.

Current antiestrogen therapy.

Current hormonal replacement therapy or oral contraceptives.

Concurrent infection.

Previous contralateral major duct excision.

NORMAL VOLUNTEERS:

Bilateral breast prosthesis.

Pregnancy.

Lactating breasts.

Current antiestrogen therapy.

Current hormonal replacement therapy or oral contraceptives.

Concurrent infection.

Previous bilateral major duct excision.

History of therapeutic mediastinal radiation.

Special Instructions: Currently Not Provided

Keywords:

Molecular Profiling

Proteomic Tissue

Lysate Arrays

Ductal Changes

Effects of Estrogen

Comparative Genomic Hybridization

Recruitment Keywords:

Breast Cancer

Post Menopausal

Breast Duct

Healthy Volunteer

HV

Normal Control

Conditions:

Breast Neoplasms

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Fisher B, et al Lumpectomy compared with lump[PMID:8292119]

Greenlee RT, et al Cancer statistics, 2000[PMID:10735013]

Fisher B, et al Tamoxifen in treatment of int[PMID:10376613]

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