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NCT00553410 · ClinicalTrials.gov registry record · Phase 3
Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
A Phase 3 study, sponsored by ETOP IBCSG Partners Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,884
- Enrollment target
NCT00553410: Completed Phase 3 study, sponsored by ETOP IBCSG Partners Foundation.
NCT00553410 is a Phase 3 study that has completed, run by ETOP IBCSG Partners Foundation. The registered enrollment target is 4,884 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (533% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00553410, a Phase 3 study, has completed, sponsored by ETOP IBCSG Partners Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,884 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.
Primary Outcome
Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence
Interventions
- DRUG Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,884 participants |
| Start Date | 2007-08 |
| Est. Completion | 2019-05-15 |
| Phase | Phase 3 |
What the finished NCT00553410 record still lists
NCT00553410 is an interventional study that assigns participants to a tested intervention. Its 4,884 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 (533% higher).
The record links to 0 conditions, and to 1 intervention - of which Letrozole is the first listed.
NCT00553410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00553410 about?
NCT00553410 is a clinical study titled "Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer". RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast canc...
What is the current status of trial NCT00553410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,884 participants. The study started on 2007-08. Estimated completion is 2019-05-15.
What interventions are being tested in trial NCT00553410?
The interventions under investigation include: Letrozole (DRUG).
Who is sponsoring clinical trial NCT00553410?
This trial is sponsored by ETOP IBCSG Partners Foundation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00553410's enrollment target sits among peer trials
4,884 52nd of 2000 higher than 1,949 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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