Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

July 27, 2012 updated by: M.D. Anderson Cancer Center

The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage fluids of Breast Cancer patients.

Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of developing breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients receiving standard Arimidex treatment.

Description

Inclusion Criteria:

  • Patient must have a history of breast cancer.
  • Patient must be scheduled to receive standard treatment with Arimidex for adjuvant hormonal management.
  • Patient must be willing to undergo a duct lavage.
  • Patient must sign an Informed Consent.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer Patients
Procedure: Ductal Lavage Fluid Collection
Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Antiproliferative Effects of Arimidex
Time Frame: Study duration 4 years
Biomarker modulation study on effects of Armimidex in ductal lavage fluid from evaluable epithelial cells specimen.
Study duration 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Study Chair: Banu Arun, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAB02-0400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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