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Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer

NCT00073073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2016-05-17

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Exemestane

exemestane 25 mg by mouth (PO) every day for two years

DIETARY_SUPPLEMENT

Calcium carbonate

calcium carbonate 1200 mg PO every day x 2 years

DIETARY_SUPPLEMENT

Vitamin D

Vitamin D 400 international units PO every day x 2 years

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Georgetown University

    lead OTHER

Principal Investigators

  • Suparna B Wedam, M.D. · National Cancer Institute, National Institutes of Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00073073 on ClinicalTrials.gov