Study of Ductal Lavage in Women at High Risk for Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer. Secondary Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants. Analyze the nipple aspirate fluid from these participants for specific and global protein signatures. Determine the replicability of markers in serial assays of these participants. Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy. OUTLINE: This is a multicenter study. Participants undergo nipple aspirate fluid and ductal lavage fluid collection. Fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. Protein patterns are identified using mass spectrometry. Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. Participants with normal fluid samples undergo repeat lavage at 1 year. PROJECTED ACCRUAL: A total of 30 participants will accrued for this study within 2-3 months.

Official Title
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Ductal Lavage to Monitor and Treat High Risk Women

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: fluorescence in situ hybridization
* Genetic: polymerase chain reaction
* Genetic: proteomic profiling
* Other: cytology specimen collection procedure
* Other: immunohistochemistry staining method
* Procedure: breast duct lavage


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: High risk for breast cancer defined as 1 of the following: History of atypical hyperplasia or atypia found on biopsy, fine-needle aspiration, or ductal lavage Family history of cancer meeting at least 1 of the following criteria: Single relative with multiple primary cancers One or more relative under 40 years of age with breast cancer OR bilateral breast cancer Two or more relatives with ovarian cancer Two or more relatives with breast cancer and 1 is under 50 years of age One or more relative with breast cancer plus ≥ 1 relative with ovarian cancer Ashkenazi Jewish descent AND relative with breast cancer under 50 years of age OR ovarian cancer at any age BRCA1 and/or BRCA2 mutation Prior breast cancer in contralateral breast Gail risk > 1.7% Spontaneous nipple discharge Serum estradiol > 10 pmol/L Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Able to obtain breast duct fluids PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 4 months since prior tamoxifen or raloxifene Radiotherapy No prior radiotherapy to the breast Surgery No prior incisional or excisional biopsy within 1.5 cm of nipple Other No prior neoadjuvant therapy

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: fluorescence in situ hybridization|nan|
|Genetic: polymerase chain reaction|nan|
|Genetic: proteomic profiling|nan|
|Other: cytology specimen collection procedure|nan|
|Other: immunohistochemistry staining method|nan|
|Procedure: breast duct lavage|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of atypical cells per ductal lavage sample |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis |  |  | 
| Specific and global protein signature analysis of nipple aspirate |  |  | 
| Replicability of markers in serial assays |  |  | 
| Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer