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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: Completed Phase 2 study, sponsored by The Methodist Hospital Research Institute.
NCT01097642 is a Phase 2 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance o
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 |
What the finished NCT01097642 record still lists
NCT01097642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT01097642 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01097642's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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