Breast Cancer
Conditions
Keywords
breast cancer
Brief summary
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
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.
Interventions
OTHERcytology specimen collection procedure
OTHERimmunohistochemistry staining method
GENETICfluorescence in situ hybridization
GENETICpolymerase chain reaction
GENETICproteomic profiling
PROCEDUREbreast duct lavage
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average number of atypical cells per ductal lavage sample | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed