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NCT00248170 · ClinicalTrials.gov registry record · Phase 3
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,172
- Enrollment target
- 20
- Study locations
NCT00248170 is a Phase 3 study of Breast Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 4,172 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT00248170, a Phase 3 study of Breast Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,172 participants
- Enrollment target
- 20
- Study locations
Study Summary
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
Study Locations (20)
Florida
- Florida Cancer Specialists - Fort Meyers
- Sarah Cannon Research Institute - Jacksonville
- Cancer Centers of Florida PA - Ocoee
- Florida Cancer Institute - Orlando
- Gulfcoast Oncology Associates - St. Petersburg
Alabama
- Birmingham Hematology and Oncology Associates - Birmingham
- Comprehensive Cancer Institute - Huntsville
Kansas
- Kansas City Cancer Center - Overland Park
- Wichita Community Clinical Oncology Program - Wichita
Ohio
- Aultman Cancer Center - Canton
- Sarah Cannon Oncology Hematology Care, Inc - Cincinnati
Arizona
- Northern Arizona Hematology/Oncology Associates, P.C. - Flagstaff
Connecticut
- Oncology & Hematology Associates, PC - New London
Georgia
- University Cancer & Blood Center, LLC - Athens
Indiana
- Central Indiana Cancer Centers - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,172 participants |
| Start Date | 2005-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00248170
The ClinicalTrials.gov registry entry for NCT00248170 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,172 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (49% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 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 Anastrozole is the first listed.
NCT00248170 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Alabama, Kansas.
Frequently Asked Questions
What is clinical trial NCT00248170 about?
NCT00248170 is a clinical study titled "Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer". Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years afte...
What is the current status of trial NCT00248170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,172 participants. The study started on 2005-12. Estimated completion is 2014-09.
What conditions does trial NCT00248170 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00248170?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG).
Who is sponsoring clinical trial NCT00248170?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00248170 being conducted?
This trial has 20 study locations across Alabama, Arizona, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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