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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 completed.
First Received: May 14, 2004   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00083044
  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 Intervention Phase
Breast Cancer
 Drug: tamoxifen citrate
Genetic: cytogenetic analysis
Genetic: protein expression analysis
Other: cytology specimen collection procedure
Other: laboratory biomarker analysis
Procedure: breast duct lavage
 Phase II

Study Type: Interventional
Study Design: Diagnostic, Open Label
Official Title: Surrogate Endpoints in Prevention Studies and Ductal Lavage

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Tamoxifen Tamoxifen citrate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect [ Designated as safety issue: No ]
  • Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples [ Designated as safety issue: No ]
  • Protein profile of nipple aspiration fluid before and after study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2003
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
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
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
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.
Bhandare DJ, Khan SA, Motchoulskaia NA, Melnikov AA, Levenson Chernokhvostov VV. Isolation of highly purified DNA from low-abundance archived and stained cytological specimens. Clin Chim Acta. 2006 May;367(1-2):211-3. Epub 2006 Feb 2. No abstract available.
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.
Li J, Zhao J, Yu X, Lange J, Kuerer H, Krishnamurthy S, Schilling E, Khan SA, Sukumar S, Chan DW. Identification of biomarkers for breast cancer in nipple aspiration and ductal lavage fluid. Clin Cancer Res. 2005 Dec 1;11(23):8312-20.
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.

Study ID Numbers: CDR0000361952, NU-0649-003
Study First Received: May 14, 2004
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00083044     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer
breast cancer in situ
stage I breast cancer
lobular breast carcinoma in situ
ductal breast carcinoma in situ

Study placed in the following topic categories:
Estrogen Antagonists
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Citric Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
 Hormones
Tamoxifen
Carcinoma
Estrogen Receptor Modulators
Carcinoma, Lobular
Carcinoma in Situ
Citrate
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Breast Diseases

Additional relevant MeSH terms:
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Bone Density Conservation Agents
 Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on September 03, 2009



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