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NCT00634634 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
A Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00634634: Completed Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
NCT00634634 is a Phase 1 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634634, a Phase 1 study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Primary Outcome
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
Interventions
- DRUG Letrozole
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2008-08-11 |
| Est. Completion | 2023-04-28 |
| Phase | Phase 1 |
What the finished NCT00634634 record still lists
NCT00634634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Letrozole is the first listed.
NCT00634634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00634634 about?
NCT00634634 is a clinical study titled "Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer". Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by bl...
What is the current status of trial NCT00634634?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2008-08-11. Estimated completion is 2023-04-28.
What interventions are being tested in trial NCT00634634?
The interventions under investigation include: Letrozole (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00634634?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00634634's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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