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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

September 21, 2010
July 27, 2012
November 2002
January 2006   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01207635 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

Blood drawn; and, fluids collected from ductal lavage.

Non-Probability Sample

Breast cancer patients receiving standard Arimidex treatment.

Breast Cancer
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.
Breast Cancer Patients
Intervention: Procedure: Ductal Lavage Fluid Collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2006
January 2006   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01207635
LAB02-0400
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Banu Arun, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP