Protocol for Women at Increased Risk of Developing Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2003 |
| End Date: | December 2009 |
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
To assess the effects of twelve months of celecoxib administration by evaluating breast
tissue needle aspirations, to determine if cell growth can be slowed.
tissue needle aspirations, to determine if cell growth can be slowed.
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.
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
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