Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Surrogate Endpoints in Prevention Studies and Ductal Lavage

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect |  | Before and after tamoxifen treatment | 
| Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples |  | At time of each ductal lavage. | 
| Protein profile of nipple aspiration fluid before and after tamoxifen treatment |  | Before and after tamoxifen treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast cancer in situ, stage I breast cancer, lobular breast carcinoma in situ, ductal breast carcinoma in situ