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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system.

Outcome Time Frame:

baseline, 12 months

Safety Issue:

No

Principal Investigator

Carol J Fabian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

9118

NCT ID:

NCT00291694

Start Date:

April 2003

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • breast atypia
  • double-blind randomized clinical trial
  • RCT
  • celecoxib
  • COX-2 inhibitor
  • placebo
  • high risk for breast cancer
  • breast epithelial hyperplasia
  • ki-67
  • chemoprevention
  • Breast Neoplasms
  • Hyperplasia

Name

Location
University of Kansas Medical Center Kansas City, Kansas  66160-7353