Suspended

Surrogate Endpoints in Prevention Studies and Ductal Lavage

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

From 18 to 64 Years
See all eligibility criteria
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
See protocol details

Summary

Principal SponsorNorthwestern University
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleSurrogate Endpoints in Prevention Studies and Ductal Lavage 
NCT00083044
Principal SponsorNorthwestern University
Last updated: January 18, 2026
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.

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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

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 Birmingham

Birmingham, United StatesSee the location
Suspended

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, United States
Suspended2 Study Centers