A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer - NCT00879086-90250A (Clinical Trial 283368)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy283368.aspx
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| City: |
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Hawthorne |
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State:
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CA |
| Zip Code: |
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90250 |
| 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. Subjects with missing digits required for vibration assessment. 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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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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February 17, 2010 |
Modifications to
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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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