Study of Ductal Lavage in Women at High Risk for Breast Cancer - Full Text View

Sponsors and Collaborators:	UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00429988

Purpose

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 that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.

Condition	Intervention
Breast Cancer	Procedure: breast duct lavage Procedure: cytology specimen collection procedure Procedure: diagnostic procedure Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: polymerase chain reaction Procedure: proteomic profiling

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Ductal Lavage to Monitor and Treat High Risk Women

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Average number of atypical cells per ductal lavage sample [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis [ Designated as safety issue: No ]
Specific and global protein signature analysis of nipple aspirate [ Designated as safety issue: No ]
Replicability of markers in serial assays [ Designated as safety issue: No ]
Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy [ Designated as safety issue: No ]

Study Start Date:

August 2002

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429988

Locations

United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115

Sponsors and Collaborators

UCSF Helen Diller Family Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Laura J. Esserman, MD, MBA

UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000378088, UCSF-TEMP01
Study First Received:	January 30, 2007
Last Updated:	December 25, 2007
ClinicalTrials.gov Identifier:	NCT00429988 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009