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This study has been withdrawn prior to enrollment.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:
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
  Purpose

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.


Condition Phase
Breast Cancer
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surrogate Endpoints in Prevention Studies and Ductal Lavage

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: October 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  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: NCT00083044

Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

Publications:
Bhandare DJ, Nayar R, Masood S, et al.: Reproducibility of ductal lavage findings in high-risk women. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-4015, 2005.
Fackler MJ, Malone K, Schilling E, et al.: Methylated genes in ductal lavage fluid from women with known breast cancer undergoing mastectomy. [Abstract] Breast Cancer Res Treat 94 (Suppl 1): A-2007, S85, 2005.
Bhandare D, Bryk M, Nayar R, et al.: Effect of Tamoxifen (TAM) on estrogen-related biomarkers in ductal lavage (DL) samples a study on follow-up lavages. [Abstract] Breast Cancer Research and Treatment 88 (Suppl 1): A-4031, 2004.
Bhandare D, Golewale N, Geiger A, et al.: Estrogen related biomarkers and cellular atypia in ductal lavage (DL) samples from women at high risk for breast cancer. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-1032, S178, 2003.
Didwania A, Golewale NH, Khan SA, et al.: Influence of ductal lavage (DL) findings on tamoxifen decision for high risk women. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-1037, S179, 2003.
Gorla SR, Steel J, Cohn R, et al.: Impact of surgical resection of primary breast tumor in stage IV breast cancer on local control and survival. [Abstract] J Clin Oncol 23 (Suppl 16): A-629, 35s, 2005.
Golewale NH, Bryk M, Nayar R, et al.: Technical modifications of ductal lavage to improve cell yield. [Abstract] Breast Cancer Research and Treatment 82 (Suppl 1): A-1024, 2003.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00083044     History of Changes
Other Study ID Numbers: GRANT P50CA89018, NU-0649-003
Study First Received: May 14, 2004
Last Updated: April 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
breast cancer
breast cancer in situ
stage I breast cancer
lobular breast carcinoma in situ
ductal breast carcinoma in situ

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

ClinicalTrials.gov processed this record on August 28, 2014