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NCT00038467 · ClinicalTrials.gov registry record · Phase 3
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,740
- Enrollment target
NCT00038467: Completed Phase 3 study, sponsored by Pfizer.
NCT00038467 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 4,740 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (514% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038467, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,740 participants
- Enrollment target
Study Summary
To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.
Primary Outcome
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relaps
Interventions
- DRUG Tamoxifen
- DRUG Exemestane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,740 participants |
| Start Date | 1998-02 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00038467 record still lists
NCT00038467 is an interventional study that assigns participants to a tested intervention. Its 4,740 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (514% higher).
The record links to 0 conditions, and to 2 interventions - of which Tamoxifen is the first listed.
NCT00038467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038467 about?
NCT00038467 is a clinical study titled "Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer". To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of co...
What is the current status of trial NCT00038467?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,740 participants. The study started on 1998-02. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00038467?
The interventions under investigation include: Tamoxifen (DRUG), Exemestane (DRUG).
Who is sponsoring clinical trial NCT00038467?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00038467's enrollment target sits among peer trials
4,740 54th of 2000 higher than 1,947 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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