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Investigator(s):
David N. Danforth, M.D., M.S. Principal Investigator Phone: 301-496-1533

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Primary Eligibility:

Breast cancer patients:

• Diagnosis of ipsilateral breast cancer of epithelial origin (invasive or noninvasive)
• 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
• More than 1 month since prior chemotherapy
• No prior radiotherapy to the contralateral breast
• No contralateral breast prosthesis, prior contralateral major duct excision, or lactating breast

Healthy volunteers:

• Gail model risk index < 1.67%
• Both breasts must be free of any suspicious areas by physical examination and mammogram
• No prior atypical hyperplasia or invasive or in situ carcinoma
• No prior therapeutic mediastinal radiotherapy
• No prior bilateral major duct excision, bilateral breast prosthesis, or lactating breasts

Both Groups

• 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 > 40 IU/mL and a serum estradiol level < 40 pg/mL
• No concurrent antiestrogen therapy
• No concurrent hormone replacement therapy or oral contraceptives
• WBC > 2,500/mm³ platelet count > 50,000/mm³
• Not pregnant or lactating

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Study Outline:

• Participants undergo breast duct lavage (in the contralateral breast for breast cancer patients and in either normal breast for healthy volunteers) and breast duct endoscopy
• Participants found to have cytologic atypia may undergo MRI and/or galactography to further characterize 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

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/8/09
Updated: 3/3/09