At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal female (no menses ≥12 months, bilateral oophorectomy, or FSH >35 U/L if unclear)
- ✓Elevated breast cancer risk: Gail model ≥1.7% over 5 years, lobular neoplasia, atypical ductal hyperplasia, prior DCIS treated with mastectomy/lumpectomy and radiation, BRCA1/2 mutations or ≥20% a priori risk, or prior stage I/II breast cancer ≥2 years from treatment
- ✓ECOG performance status 0-1
- ✓Baseline DEXA scan with BMD T-score ≥-2.5 at anteroposterior spine
- ✕Current or recent chronic use (within 3 months) of hormonal medications including OCPs, HRT, tamoxifen, raloxifene, progestin IUDs (except E-string)
- ✕History of allergy to aromatase inhibitors (anastrozole, letrozole, formestane)
- ✕Concurrent use of phenytoin, carbamazepine, or rifampin (increased estrogen metabolism)
- ✕History of clotting or bleeding disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Trial of Exemestane in Postmenopausal Women With DCIS or at High Risk for Invasive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Exemestane, Calcium carbonate, and 1 other intervention for Breast Neoplasms. Completed, enrolled 46 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
exemestane 25 mg by mouth (PO) every day for two years
calcium carbonate 1200 mg PO every day x 2 years
Vitamin D 400 international units PO every day x 2 years