NCT00291109

Brief Summary

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to letrozole

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

First QC Date

February 10, 2006

Last Update Submit

September 15, 2008

Conditions

Breast Cancer

Keywords

breast atypiabreast epithelial hyperplasiaKi-67RTPCRmicrodissection

Interventions

letrozole 2.5 mgDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
  • on hormone replacement therapy
  • postmenopausal
  • increased risk of developing breast cancer based on personal or family history
  • never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
  • women who have a high risk of breast cancer
  • older than 18 years

You may not qualify if:

  • no anticoagulants
  • no marked breast tenderness
  • not pregnant or within twelve months of breast feeding/childbirth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Carol J Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

January 1, 2003

Study Completion

July 1, 2005

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

US(1)