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

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 Procedure: breast duct lavage Procedure: cytogenetic analysis Procedure: cytology specimen collection procedure Procedure: laboratory biomarker analysis Procedure: protein expression analysis	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Tamoxifen Tamoxifen citrate Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label

Official Title:	Surrogate Endpoints in Prevention Studies and Ductal Lavage

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

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

Publications of Results:

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.

Other Publications:

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
First Received:	May 14, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00083044
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:

Carcinoma, Lobular

Skin Diseases

Carcinoma in Situ

Citric Acid

Breast Neoplasms

Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating

Tamoxifen

Breast Diseases

Carcinoma

Additional relevant MeSH terms:

Estrogen Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Bone Density Conservation Agents

Selective Estrogen Receptor Modulators

Pharmacologic Actions

Estrogen Receptor Modulators

Neoplasms

Neoplasms by Site

Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00083044