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NCT00016432 · ClinicalTrials.gov registry record · Phase 3
Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
A Phase 3 study of Breast Cancer, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,598
- Enrollment target
- 20
- Study locations
NCT00016432 is a Phase 3 study of Breast Cancer that has completed, run by NSABP Foundation. The registered enrollment target is 1,598 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT00016432, a Phase 3 study of Breast Cancer, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,598 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG exemestane
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- California Cancer Center - Fresno
- Sutter Health Western Division Cancer Research Group - Greenbrae
- Scripps Cancer Center - La Jolla
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Loma Linda University Cancer Institute - Loma Linda
- Pacific Shores Medical Group - Long Beach
- Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
- Chao Family Comprehensive Cancer Center - Orange
- Comprehensive Cancer Centers of the Desert - Palm Springs
- Sutter Cancer Center - Sacramento
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego - San Diego
- CCOP - Santa Rosa Memorial Hospital - Santa Rosa
- Stanford University Medical Center - Stanford
- Kaiser Permanente Medical Center - Vallejo - Vallejo
Colorado
- University of Colorado Cancer Center - Denver
- CCOP - Colorado Cancer Research Program, Incorporated - Denver
Alabama
- Comprehensive Cancer Institute of Huntsville - Huntsville
Arizona
- CCOP - Greater Phoenix - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,598 participants |
| Start Date | 2001-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00016432
The ClinicalTrials.gov registry entry for NCT00016432 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,598 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (43% lower). The listed sponsor is NSABP Foundation, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00016432 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT00016432 about?
NCT00016432 is a clinical study titled "Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen". RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Random...
What is the current status of trial NCT00016432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,598 participants. The study started on 2001-05. Estimated completion is 2011-02.
What conditions does trial NCT00016432 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00016432?
The interventions under investigation include: Placebo (DRUG), exemestane (DRUG).
Who is sponsoring clinical trial NCT00016432?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00016432 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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