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Surrogate Endpoints in Prevention Studies and Ductal Lavage


Phase 2
18 Years
64 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

Surrogate Endpoints in Prevention Studies and Ductal Lavage


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect

Outcome Time Frame:

Before and after tamoxifen treatment

Safety Issue:

No

Principal Investigator

Seema A. Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

GRANT P50CA89018

NCT ID:

NCT00083044

Start Date:

October 2003

Completion Date:

July 2008

Related Keywords:

  • Breast Cancer
  • breast cancer
  • breast cancer in situ
  • stage I breast cancer
  • lobular breast carcinoma in situ
  • ductal breast carcinoma in situ
  • Breast Neoplasms

Name

Location

Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611