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Ductal Lavage to Monitor and Treat High Risk Women


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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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 CenterSan Francisco, California  94115