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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 is a Phase 2 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00821886
The ClinicalTrials.gov registry entry for NCT00821886 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00821886 reports 0 study locations.
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.
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