Ductal Lavage to Monitor and Treat High Risk Women
18 Years
N/A
Female
Breast Cancer
Trial Information
Ductal Lavage to Monitor and Treat High Risk Women
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Average number of atypical cells per ductal lavage sample
Safety Issue:
No
Principal Investigator
Laura J. Esserman, MD, MBA
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Federal Government
Study ID:
CDR0000378088
NCT ID:
NCT00429988
Start Date:
August 2002
Completion Date:
June 2004
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
