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NCT00821886 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer
A Phase 2 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00821886: Completed Phase 2 study, sponsored by SCRI Development Innovations.
NCT00821886 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00821886, a Phase 2 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixabepilone, carboplatin, and trastuzumab every three weeks prior to surgery; after surgery, patients will continue treatment with trastuzumab every three weeks until week 52. Concomitant with the post-operative trastuzumab treatment, patients with hormone receptor-positive tumors will receive anti-estrogen treatment. Also, after the completion of chemotherapy, patients may receive radiation treatment at the discretion of their physician.
Primary Outcome
Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery
Interventions
- DRUG Trastuzumab
- DRUG Carboplatin
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT00821886 record still lists
NCT00821886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00821886 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00821886 about?
NCT00821886 is a clinical study titled "Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer". In this phase II trial the investigators propose to evaluate ixabepilone in combination with carboplatin and trastuzumab as neoadjuvant therapy in locally advanced breast cancer patients. Patients with early stage, HER2-positive breast cancer will receive six cycles of neoadjuvant treatment with ixa...
What is the current status of trial NCT00821886?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2009-02. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00821886?
The interventions under investigation include: Trastuzumab (DRUG), Carboplatin (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00821886?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00821886's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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