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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01207635
First received: September 21, 2010
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer patients receiving standard Arimidex treatment.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207635

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01207635     History of Changes
Other Study ID Numbers: LAB02-0400
Study First Received: September 21, 2010
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Arimidex

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014