Status:
WITHDRAWN
Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-64 years
Brief 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 asse...
Detailed 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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00083044
Start Date
October 1 2003
End Date
July 1 2008
Last Update
April 25 2012
Active Locations (2)
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1
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013