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



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

For Condition: breast cancer in situ,intraductal breast carcinoma,Breast Cancer,stage 1 breast cancer,lobular breast carcinoma in situ
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of ductal lavage in assessing changes in breast cells in women who either have early breast cancer or are at high risk of developing breast cancer and are eligible for tamoxifen therapy.
Details: 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:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry 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* - Hormone-receptor status: - Estrogen receptor-positive (in patients with small invasive breast cancer) NOTE: *Only the unaffected breast will be examined during this study 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SeemaKhan,  Principal Investigator,  Robert H. Lurie Cancer Center

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Helen  Krontiras 205-934-3028

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611-3013
United States
Recruiting Seema  Khan 312-908-5250


Additional Information:
Study ID Numbers:
  CDR0000361952;  NU-0649-003
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083044

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