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

This study has been withdrawn prior to enrollment.
(Funding ended and will not be renewed)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00083044
First received: May 14, 2004
Last updated: April 24, 2012
Last verified: April 2012
History of Changes

May 14, 2004
April 24, 2012
October 2003
July 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Protein profile of nipple aspiration fluid before and after tamoxifen treatment [ Time Frame: Before and after tamoxifen treatment. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00083044 on ClinicalTrials.gov Archive Site
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Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women with early breast cancer or at high risk of developing breast cancer and who are eligible for tamoxifen therapy
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083044
GRANT P50CA89018, NU-0649-003
No
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
Northwestern University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP