Surrogate Endpoints in Prevention Studies and Ductal Lavage
Data Collection
Collected from today forward - ProspectiveBreast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, United StatesSee the locationRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United States