NCT01207635

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

September 21, 2010

Last Update Submit

July 27, 2012

Conditions

Breast Cancer

Keywords

CancerArimidex

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Breast Cancer Patients

Procedure: Ductal Lavage Fluid Collection

Interventions

Ductal Lavage Fluid CollectionPROCEDURE

Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.

Breast Cancer Patients

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients receiving standard Arimidex treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: NONE RETAINED

Blood drawn; and, fluids collected from ductal lavage.

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Banu Arun, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 23, 2010

Study Start

November 1, 2002

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)