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NCT00073073 · ClinicalTrials.gov registry record · Phase 2
Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer
A Phase 2 study of Breast Neoplasms, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 2
- Study locations
NCT00073073: Completed Phase 2 study of Breast Neoplasms, sponsored by Georgetown University.
NCT00073073 is a Phase 2 study of Breast Neoplasms that has completed, run by Georgetown University. The registered enrollment target is 46 participants, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00073073, a Phase 2 study of Breast Neoplasms, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 2
- Study locations
Study 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 te
Conditions Studied
Interventions
- DRUG Exemestane
- DIETARY_SUPPLEMENT Vitamin D
- DIETARY_SUPPLEMENT Calcium carbonate
Study Locations (2)
District of Columbia
- Lombardi Cancer Center, Georgetown University - Washington D.C.
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2003-11 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00073073 record still lists
NCT00073073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 569-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Exemestane is the first listed.
NCT00073073 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00073073 about?
NCT00073073 is a clinical study titled "Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer". 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 cance...
What is the current status of trial NCT00073073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2003-11. Estimated completion is 2011-12.
What conditions does trial NCT00073073 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT00073073?
The interventions under investigation include: Exemestane (DRUG), Vitamin D (DIETARY_SUPPLEMENT), Calcium carbonate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00073073?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00073073 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00073073's enrollment target sits among peer trials
46 76th of 97 higher than 22 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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