Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Diagnostic, Prevention, Treatment	Completed	18 to 64	NCI, Other	CDR0000361952 NU-0649-003, NCT00083044

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Seema A. Khan

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00083044
Information obtained from ClinicalTrials.gov on March 18, 2010

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