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NCT00044291 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
A Phase 3 study of Breast Neoplasms and Neoplasms, Hormone-dependent, sponsored by Intarcia Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 865
- Enrollment target
- 20
- Study locations
NCT00044291 is a Phase 3 study of Breast Neoplasms and Neoplasms, Hormone-dependent that has completed, run by Intarcia Therapeutics. The registered enrollment target is 865 participants, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (54% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT00044291, a Phase 3 study of Breast Neoplasms and Neoplasms, Hormone-dependent, has completed, sponsored by Intarcia Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 865 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.
Conditions Studied
Interventions
- DRUG letrozole
- DRUG atamestane
- DRUG toremifene
- DRUG aromatase inhibition
- PROCEDURE hormone therapy
Study Locations (20)
Ontario
- Ottawa Regional Cancer Centre - Ottawa
- Northwestern Ontario Regional Cancer Centre - Thunder Bay
- Princess Margaret Hospital - Toronto
Arizona
- Midwest Internal Medicine, PLLC - Lake Havasu City
- Arizona Clinical Research Center - Tucson
California
- California Cancer Care, Inc. - Greenbrae
- Sharp Memorial Hospital - San Diego
Texas
- Oncology Consultants - Houston
- First Dynamic Healthcare Services, Inc. - Killeen
Florida
- Innovative Medical Research of South Florida Inc. - Miami Shores
Georgia
- Georgia Cancer Specialists - Tucker
Maryland
- Maryland Hematology/Oncology Associates - Baltimore
Michigan
- Oncology Care Associates, PLLC - Saint Joseph
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 865 participants |
| Start Date | 2002-06 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00044291
The ClinicalTrials.gov registry entry for NCT00044291 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 865 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 560-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (54% higher). The listed sponsor is Intarcia Therapeutics, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which letrozole is the first listed.
NCT00044291 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Ontario, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT00044291 about?
NCT00044291 is a clinical study titled "Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer". The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmeno...
What is the current status of trial NCT00044291?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 865 participants. The study started on 2002-06. Estimated completion is 2006-01.
What conditions does trial NCT00044291 study?
This clinical trial studies the following conditions: Breast Neoplasms, Neoplasms, Hormone-dependent.
What interventions are being tested in trial NCT00044291?
The interventions under investigation include: letrozole (DRUG), atamestane (DRUG), toremifene (DRUG), aromatase inhibition (DRUG), hormone therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00044291?
This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00044291 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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