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Completed

NCT Number: NCT00291694

Protocol for Women at Increased Risk of Developing Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Celecoxib 400 mg BID

Other names: Celebrex

Placebo

Other

placebo

Primary outcomes

  1. Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67

    Time frame: Baseline and 12 months

    Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.

Secondary outcomes

  1. Mammographic Breast Density

    Time frame: Baseline and 12 months

    The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.

  2. Serum Estradiol Concentration

    Time frame: Baseline to 12 months

    Change in serum estradiol concentration

  3. Serum Sex Hormone Binding Globulin (SHBG) Concentration

    Time frame: Baseline to 12 months

    Change in serum concentration

  4. Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3

    Time frame: baseline to 12 months

    Change ion ratio.

Sponsors and collaborators

Lead sponsor

Carol Fabian, MD

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Feb 14, 2006
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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