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

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: September 21, 2010
Last updated: July 27, 2012
Last verified: July 2012

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.

Condition Intervention
Breast Cancer
Procedure: Ductal Lavage Fluid Collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.

Biospecimen Retention:   None Retained
Blood drawn; and, fluids collected from ductal lavage.

Enrollment: 42
Study Start Date: November 2002
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients receiving standard Arimidex treatment.

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01207635

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Banu Arun, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01207635     History of Changes
Other Study ID Numbers: LAB02-0400
Study First Received: September 21, 2010
Last Updated: July 27, 2012

Keywords provided by M.D. Anderson Cancer Center:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017