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NCT00036270 · ClinicalTrials.gov registry record · Phase 3
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 9,779
- Enrollment target
NCT00036270: Completed Phase 3 study, sponsored by Pfizer.
NCT00036270 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 9,779 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00036270, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 9,779 participants
- Enrollment target
Study Summary
To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.
Primary Outcome
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercu
Interventions
- DRUG exemestane (Aromasin)
- DRUG tamoxifen + exemestane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,779 participants |
| Start Date | 2001-08 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT00036270 record still lists
NCT00036270 is an interventional study that assigns participants to a tested intervention. Its 9,779 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1168% higher).
The record links to 0 conditions, and to 2 interventions - of which exemestane (Aromasin) is the first listed.
NCT00036270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00036270 about?
NCT00036270 is a clinical study titled "Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane". To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar ye...
What is the current status of trial NCT00036270?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 9,779 participants. The study started on 2001-08. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00036270?
The interventions under investigation include: exemestane (Aromasin) (DRUG), tamoxifen + exemestane (DRUG).
Who is sponsoring clinical trial NCT00036270?
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 NCT00036270's enrollment target sits among peer trials
9,779 29th of 2000 higher than 1,972 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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