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NCT00079326 · ClinicalTrials.gov registry record · Phase 2
Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00079326: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00079326 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079326, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL trastuzumab
- DRUG ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2004-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
Why NCT00079326 stopped before completion
NCT00079326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.
NCT00079326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00079326 about?
NCT00079326 is a clinical study titled "Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer". This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harmi...
What is the current status of trial NCT00079326?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2004-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00079326?
The interventions under investigation include: laboratory biomarker analysis (OTHER), trastuzumab (BIOLOGICAL), ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00079326?
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 NCT00079326's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 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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