Surrogate Endpoints in Prevention Studies and Ductal Lavage
18 Years
64 Years
Female
Breast Cancer
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 Birmingham | Birmingham, Alabama 35294 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
