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NCT00601900 · ClinicalTrials.gov registry record · Phase 3
Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 394
- Enrollment target
NCT00601900: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00601900 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 394 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601900, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 394 participants
- Enrollment target
Study Summary
This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.
Primary Outcome
The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Letrozole
- BIOLOGICAL Bevacizumab
- DRUG Tamoxifen Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2008-09-24 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 3 |
What the finished NCT00601900 record still lists
NCT00601900 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00601900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00601900 about?
NCT00601900 is a clinical study titled "Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer". This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone ther...
What is the current status of trial NCT00601900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 394 participants. The study started on 2008-09-24. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT00601900?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Letrozole (DRUG), Bevacizumab (BIOLOGICAL), Tamoxifen Citrate (DRUG).
Who is sponsoring clinical trial NCT00601900?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00601900's enrollment target sits among peer trials
394 967th of 2000 higher than 1,034 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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