Breast Cancer Clinical Trial
Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen, on breast cells and may help doctors plan more effective treatment.
PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy.
Full Description
OBJECTIVES:
Evaluate cell morphology and protein expression of breast epithelial cells in ductal lavage samples as a marker of tamoxifen effect from women with breast cancer or from women at high risk for developing breast cancer.
Evaluate methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples from these participants.
Evaluate the protein profile of nipple aspiration fluid from these participants before and after treatment with tamoxifen.
OUTLINE: This is a multicenter study.
Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage. Participants are informed of cytological findings and choose to receive oral tamoxifen once daily for 5 years vs observation only. All participants undergo repeat ductal lavage at 6 months. Participants with atypical cytology undergo a third ductal lavage at 12 months.
Mammographic density is measured at study entry and at 12 months.
Ductal cells are analyzed for methylation status of candidate genes.
Participants are followed as clinically indicated.
PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Diagnosis of small invasive breast cancer
Diagnosis of ductal or lobular carcinoma in situ of the breast
At high risk for breast cancer (5-year Gail model risk of > 1.6%)
Eligible for tamoxifen therapy
No plans for adjuvant chemotherapy
Prior unilateral early breast cancer allowed* NOTE: *Only the unaffected breast will be examined during this study
Hormone-receptor status:
Estrogen receptor-positive (in patients with small invasive breast cancer)
PATIENT CHARACTERISTICS:
Age
18 to 64
Sex
Female
Menopausal Status
Premenopausal or postmenopausal
Performance status
Not specified
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Not specified
Cardiovascular
No prior venous thromboembolism
Other
At least 12 months post-partum
Not pregnant
Not nursing within the past 12 months
No known allergy to lidocaine, prilocaine, or bupivacaine
No uterine hyperplasia or polyps
No other contraindication to tamoxifen
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
See Disease Characteristics
More than 6 months since prior chemotherapy
Endocrine therapy
Concurrent hormone-replacement therapy allowed
Prior tamoxifen or raloxifene allowed provided treatment duration was no more than 6 months
At least 1 year since prior raloxifene
Radiotherapy
Not specified
Surgery
Not specified
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There are 2 Locations for this study
Birmingham Alabama, 35294, United States
Chicago Illinois, 60611, United States
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