Status:
COMPLETED
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
Lead Sponsor:
Eisai Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- Subjects who have received prior ixabepilone therapy.
- Subjects with prior participation in an eribulin clinical study, even if not assigned to eribulin treatment.
- Subjects with pre-existing neuropathy Grade greater than or equal to 2.
- Subjects with a history of diabetes mellitus Type 1 or 2.
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2014
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00879086
Start Date
March 31 2009
End Date
April 30 2014
Last Update
June 22 2023
Active Locations (50)
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1
Northern AZ Hematology and Oncology Associates
Sedona, Arizona, United States, 86336
2
Healing Hands Oncology and Medical Care
Hawthorne, California, United States, 90250
3
University of Southern California
Los Angeles, California, United States, 90033
4
Comprehensive Cancer Center
Palm Springs, California, United States, 92262