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NCT01097642 · ClinicalTrials.gov registry record · Phase 2
Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
A Phase 2 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01097642 is a Phase 2 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 40 participants.
The verdict
NCT01097642, a Phase 2 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients with metastatic breast cancer after failing other treatments. Cetuximab is active against tumors expressing epidermal growth factor receptor w/demonstrated activity in head \& neck and colorectal tumors and may be effective in some breast cancers known to express EGFR. Study seeks to evaluate Ixabepilone alone or in combination with cetuximab as a an antitumor therapy w/randomization stratified by stage (T1N1-3M0 or T2-4 N0-3M0).
Interventions
- DRUG Cetuximab
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-10-10 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01097642
The ClinicalTrials.gov registry entry for NCT01097642 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT01097642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01097642 about?
NCT01097642 is a clinical study titled "Neo-Adjuvant Study in Triple Negative Breast Cancer Patients". Ixabepilone and capecitabine combination has demonstrated to be an active regimen in patients with metastatic breast cancer after failing other treatments. Cetuximab is active against tumors expressing epidermal growth factor receptor w/demonstrated activity in head \& neck and colorectal tumors and...
What is the current status of trial NCT01097642?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2008-10-10. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01097642?
The interventions under investigation include: Cetuximab (DRUG), Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT01097642?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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