Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Breast Cancer

From 18 to 64 Years
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2003

Summary

Principal SponsorNorthwestern University
Last updated: April 25, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleSurrogate Endpoints in Prevention Studies and Ductal Lavage 
Principal SponsorNorthwestern University
Last updated: April 25, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 64 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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
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
Suspended
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, United States

Suspended2 Study Centers