A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | March 2009 |
End Date: | April 2014 |
A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer
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.
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.
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 greater than or equal to 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.
We found this trial at
50
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Southern California The University of Southern California is one of the world’s leading...
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7431 N University Dr # 110
Tamarac, Florida 33321
Tamarac, Florida 33321
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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4901 Veterans Memorial Boulevard
Metairie, Louisiana 70006
Metairie, Louisiana 70006
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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