Protocol Number: 04-C-0044

Title:

A Trial of Exemestane in Postmenopausal Women with DCIS or at High Risk for Invasive Breast Cancer

Number:

04-C-0044

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.

As of December 2004, the arm using exemestane and celecoxib is temporarily closed to accrual and is undergoing re-evaluation due to new information about a possible relationship between celecoxib and increased risk of heart attacks, strokes, and deaths resulting from blood vessel disease. We are actively accruing to the exemestane alone arm.

Postmenopausal women, defined in this study as women who have not had a menstrual period for at least 12 months or who have had both ovaries removed, 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 (surgical removal of a small sample of breast tissue for examination), and dual energy x-ray absorptionometry (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 5 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

-DEXA scan of the spine, mammogram and routine blood tests before starting study drugs and then yearly for 5 years

-Breast examination, review of side effects, and refill of study drugs every 6 months for 5 years

-Quality of life questionnaire before starting study drugs and after 1 year and 5 years on study drugs

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Chemoprevention

Mammographic Density

Bone Mineral Density

Biomarkers

Safety

Recruitment Keyword(s):

Breast Cancer

Postmenopausal

Condition(s):

Breast Neoplasms

Investigational Drug(s):

Exemestane

Investigational Device(s):

None

Interventions:

Drug: Exemestane

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Fisher B, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88.

Baum M, et al. ATAC Trialists' Group. Anastrozole alone or incombination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002 Jun22;359(9324):2131-9. Erratum in: Lancet 2002 Nov9;360(9344):1520.

Jones S, et al. Multicenter, phase II trial of exemestane as third-line hormonal therapy of postmenopausal women with metastatic breast cancer. Aromasin Study Group. J Clin Oncol. 1999 Nov;17(11):3418-25.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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