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NCT00739063 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00739063: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00739063 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer 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
NCT00739063, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. The safety of this drug will also be studied. Objectives: To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib in the treatment of patients with 'triple receptor-negative' metastatic carcinoma of the breast. Primary endpoints: 1\) Time to progression (TTP) Secondary endpoints: 1. clinical benefit rate as defined by complete and partial response and stable disease 2. overall survival (OS) 3. safety profile and tolerability of erlotinib 4. biologic correlative studies
Primary Outcome
Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.
Interventions
- DRUG Tarceva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
Why NCT00739063 stopped before completion
NCT00739063 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 Tarceva is the first listed.
NCT00739063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00739063 about?
NCT00739063 is a clinical study titled "Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer". The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. The safety of this drug will also be studied. Objectives: To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib...
What is the current status of trial NCT00739063?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2008-07. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00739063?
The interventions under investigation include: Tarceva (DRUG).
Who is sponsoring clinical trial NCT00739063?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00739063'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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