A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer - NCT00879086-75075 (Clinical Trial 283387)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy283387.aspx
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| City: |
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Plano |
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State:
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TX |
| Zip Code: |
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75075 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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The purpose of this study in patients with advanced breast cancer is to compare the
incidence and severity of neuropathy adverse events for the two treatment groups (eribulin
versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse
Events (NCI CTCAE version 3.0) grading.
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| Study summary: |
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| Criteria: |
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Inclusion criteria:
1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast
who have received prior taxane therapy and at least one prior cytotoxic chemotherapy
regimen for advanced disease.
Exclusion criteria:
1. Subjects who have received prior ixabepilone therapy.
2. Subjects with prior participation in an eribulin clinical study, even if not assigned
to eribulin treatment.
3. Subjects with pre-existing neuropathy Grade ≥ 2.
4. Subjects with a history of diabetes mellitus Type 1 or 2.
5. Subjects with bilateral mastectomy which included bilateral axillary lymph node
dissection.
6. Subjects with missing digits required for vibration assessment.
7. Subjects with any other concurrent diseases or conditions that would be expected to
interfere with neuropathy assessments, which may include vitamin deficiency, sequelae
of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy,
or alcoholic or inflammatory neuropathy. |
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| Study is available at: |
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North Texas Regional Cancer Center
Plano, TX 75075
United States
Primary Contact:
Dr. Michael * Savin
Phone: 972-867-3577
Secondary Contact:
Eisai Eisai Medical Services
Phone: 1-888-422-4743 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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