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NCT00083993 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
A Phase 3 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,236
- Enrollment target
NCT00083993 is a Phase 3 study that was terminated before completion, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 1,236 participants.
The verdict
NCT00083993, a Phase 3 study, was terminated before completion, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,236 participants
- Enrollment target
Study Summary
In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.
Interventions
- DRUG Temsirolimus (CCI-779) for 34 months
- DRUG Letrozole for 34 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,236 participants |
| Start Date | 2004-05 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00083993
The ClinicalTrials.gov registry entry for NCT00083993 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus (CCI-779) for 34 months is the first listed.
NCT00083993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00083993 about?
NCT00083993 is a clinical study titled "Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer". In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free...
What is the current status of trial NCT00083993?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,236 participants. The study started on 2004-05. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00083993?
The interventions under investigation include: Temsirolimus (CCI-779) for 34 months (DRUG), Letrozole for 34 months (DRUG).
Who is sponsoring clinical trial NCT00083993?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
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