Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
The primary goal of this 5-year study is to determine whether exemestane alone or in
combination with celecoxib decreases breast tissue density in healthy postmenopausal women at
high risk for breast cancer. Dense breast tissue seen on mammography has been linked to an
increased risk of breast cancer. The study will also examine the effects of exemestane and
celecoxib on bone density, blood hormone levels and quality of life. Exemestane, approved by
the Food and Drug Administration for treating postmenopausal women with breast cancer, lowers
the amount of estrogen in the body. Celecoxib, approved for treating arthritis pain and for
reducing the number or colon polyps in an inherited syndrome, is an anti-inflammatory drug.
Half of the women in the study will receive exemestane alone and half will receive exemestane
and celecoxib together.
In December 2004, the arm using exemestane and celecoxib was closed to accrual
Postmenopausal women who are at increased risk for developing invasive breast cancer may be
eligible to participate. Candidates are screened with breast cancer risk assessment, medical
history and physical examination, blood tests, review of medical records, if needed, breast
biopsy, and dual energy x-ray absorptiometry (DEXA) scan to assess bone density. For the DEXA
scan, the subject lies still on a table for about 30 minutes while the spine and hip are
scanned using a small amount of radiation.
Participants take exemestane in pill form once a day for 2 years. They also take calcium and
vitamin D pills daily to help protect bone health. They are followed in the clinic during the
course of the study to determine the amount of drug taken and any side effects, and for the
following tests and procedures:
- Medical evaluation and blood tests at after 1 and 3 months on study drugs
- Medical evaluation at 6 months
- Breast biopsy at screening and then at 12 months
- dual-emission x-ray absorptiometry (DEXA) scan of the spine, mammogram and routine blood
tests before starting study drugs and then yearly for 5 years.