Study of Ductal Lavage in Women at High Risk for Breast Cancer

September 25, 2012 updated by: University of California, San Francisco

Ductal Lavage to Monitor and Treat High Risk Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women at increased risk for breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Average number of atypical cells per ductal lavage sample

Secondary Outcome Measures

Outcome Measure
Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
Specific and global protein signature analysis of nipple aspirate
Replicability of markers in serial assays
Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Laura J. Esserman, MD, MBA, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000378088
  • UCSF-TEMP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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