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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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2008-10-10
Est. Completion 2019-12
Phase Phase 2

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.