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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00429988
First received: January 30, 2007
Last updated: September 25, 2012
Last verified: September 2012
  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
Genetic: fluorescence in situ hybridization
Genetic: polymerase chain reaction
Genetic: proteomic profiling
Other: cytology specimen collection procedure
Other: immunohistochemistry staining method
Procedure: breast duct lavage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ductal Lavage to Monitor and Treat High Risk Women

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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 ]

Enrollment: 30
Study Start Date: August 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Women at increased risk for breast cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Francisco
Investigators
Principal Investigator: Laura J. Esserman, MD, MBA University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00429988     History of Changes
Other Study ID Numbers: CDR0000378088, UCSF-TEMP01
Study First Received: January 30, 2007
Last Updated: September 25, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014