Status:
COMPLETED
Study of Ductal Lavage in Women at High Risk for Breast Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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 t...
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 asp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00429988
Start Date
August 1 2002
End Date
June 1 2004
Last Update
September 26 2012
Active Locations (1)
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1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115