An Examination of Predictors of Indicators of Response to... | NCT00291109

Studies
An Examination of Predictors of Indicators of Response to Letrozole 2.5 mg

NCT00291109

Sponsor

University of Kansas

Status

Completed

Last Update Posted

Sep 16, 2008Estimated

Enrollment

Phase

Not provided

Conditions

Breast Cancer

Interventions

letrozole 2.5 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Feb 10, 2006

First Submission Date that Met QC Criteria

Feb 10, 2006

First Posted Date

Feb 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2008

Last Update Posted Date

Sep 16, 2008Estimated

Description Module

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

Detailed Description

To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products (PCNA, cyclin-D1, ER alpha, PR, pS2, 450 aromatase, bcl-2, bax, caspase-3, and VEGFR) that may be useful as predictors or indicators of response to letrozole

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
letrozole 2.5 mg	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol J Fabian, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077289	Letrozole

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided