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NCT01207635 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01207635
Other study ID # LAB02-0400
Secondary ID
Status Completed
Phase N/A
First received September 21, 2010
Last updated July 27, 2012
Start date November 2002
Est. completion date January 2006

Study information
Verified date July 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States UT MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Patients with Antiproliferative Effects of Arimidex Biomarker modulation study on effects of Armimidex in ductal lavage fluid from evaluable epithelial cells specimen. Study duration 4 years No
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