Protocol for Women at Increased Risk of Developing Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 10, 2006

Last Updated Date

September 15, 2008

Start Date ^†

April 2003

Current Primary Outcome Measures ^†

Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system. [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00291694 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

serum markers for hormones and growth factors, mammographic breast density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Protocol for Women at Increased Risk of Developing Breast Cancer

Official Title ^†

A Double-Blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo

Brief Summary

To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Detailed Description

A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Breast Cancer

Intervention ^†

Drug: celecoxib
Other: placebo

Study Arms / Comparison Groups

Active Comparator: Celecoxib
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

women who have a high risk of breast cancer
older than 18 years

Exclusion Criteria:

anticoagulants
marked breast tenderness
pregnant or within twelve months of breast feeding/childbirth

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00291694

Responsible Party

Carol Fabian, University of Kansas Medical Center

Secondary IDs ^††

Study Sponsor ^†

University of Kansas

Collaborators ^††

Susan G. Komen Breast Cancer Foundation

Investigators ^†

Principal Investigator:

Carol J Fabian, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.