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NCT00597597 · ClinicalTrials.gov registry record · Phase 2
Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
A Phase 2 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00597597: Clinical Trial Phase 2 study, sponsored by Rush University Medical Center.
NCT00597597 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597597, a Phase 2 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.
Primary Outcome
From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death.
Interventions
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
Why NCT00597597 stopped before completion
NCT00597597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.
NCT00597597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00597597 about?
NCT00597597 is a clinical study titled "Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer". The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset...
What is the current status of trial NCT00597597?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2007-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00597597?
The interventions under investigation include: Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00597597?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00597597's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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