Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy

April 24, 2012 updated by: Northwestern University

Surrogate Endpoints in Prevention Studies and Ductal Lavage

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Diagnostic procedures, such as ductal lavage, may improve the ability to assess the effectiveness of chemopreventive drugs, such as tamoxifen, on breast cells and may help doctors plan more effective treatment.

PURPOSE: This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

OBJECTIVES:

  • Evaluate cell morphology and protein expression of breast epithelial cells in ductal lavage samples as a marker of tamoxifen effect from women with breast cancer or from women at high risk for developing breast cancer.
  • Evaluate methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples from these participants.
  • Evaluate the protein profile of nipple aspiration fluid from these participants before and after treatment with tamoxifen.

OUTLINE: This is a multicenter study.

Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage. Participants are informed of cytological findings and choose to receive oral tamoxifen once daily for 5 years vs observation only. All participants undergo repeat ductal lavage at 6 months. Participants with atypical cytology undergo a third ductal lavage at 12 months.

Mammographic density is measured at study entry and at 12 months.

Ductal cells are analyzed for methylation status of candidate genes.

Participants are followed as clinically indicated.

PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.

Study Type

Observational

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Comprehensive Cancer Center at University of Alabama at Birmingham
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

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 to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with early breast cancer or at high risk of developing breast cancer and who are eligible for tamoxifen therapy

Description

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of small invasive breast cancer
    • Diagnosis of ductal or lobular carcinoma in situ of the breast
    • At high risk for breast cancer (5-year Gail model risk of > 1.6%)
  • Eligible for tamoxifen therapy
  • No plans for adjuvant chemotherapy
  • Prior unilateral early breast cancer allowed* NOTE: *Only the unaffected breast will be examined during this study

  • Hormone-receptor status:

    • Estrogen receptor-positive (in patients with small invasive breast cancer)

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Sex

  • Female

Menopausal Status

  • Premenopausal or postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No prior venous thromboembolism

Other

  • At least 12 months post-partum
  • Not pregnant
  • Not nursing within the past 12 months
  • No known allergy to lidocaine, prilocaine, or bupivacaine
  • No uterine hyperplasia or polyps
  • No other contraindication to tamoxifen

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Concurrent hormone-replacement therapy allowed
  • Prior tamoxifen or raloxifene allowed provided treatment duration was no more than 6 months
  • At least 1 year since prior raloxifene

Radiotherapy

  • Not specified

Surgery

  • Not specified

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
Time Frame
Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect
Time Frame: Before and after tamoxifen treatment
Before and after tamoxifen treatment
Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples
Time Frame: At time of each ductal lavage.
At time of each ductal lavage.
Protein profile of nipple aspiration fluid before and after tamoxifen treatment
Time Frame: Before and after tamoxifen treatment.
Before and after tamoxifen treatment.

Collaborators and Investigators

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

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 14, 2004

First Posted (Estimate)

May 17, 2004

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRANT P50CA89018
  • NU-0649-003

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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