A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
NCT ID: NCT00879086
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2009-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eribulin mesylate
Eribulin Mesylate
E7389 (eribulin mesylate) given at a dose of 1.4 mg/m\^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Ixabepilone
Ixabepilone
Ixabepilone given at a starting dose of 32 or 40 mg/m\^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Interventions
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Eribulin Mesylate
E7389 (eribulin mesylate) given at a dose of 1.4 mg/m\^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Ixabepilone
Ixabepilone given at a starting dose of 32 or 40 mg/m\^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Northern AZ Hematology and Oncology Associates
Sedona, Arizona, United States
Healing Hands Oncology and Medical Care
Hawthorne, California, United States
University of Southern California
Los Angeles, California, United States
Comprehensive Cancer Center
Palm Springs, California, United States
Comprehensive Cancer Care Specialist of Boca
Boca Raton, Florida, United States
Robert R. Carroll, MD, PA
Gainesville, Florida, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
Medical Specialists of the Palm Beaches
Lake Worth, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Oncology and Hematology Associates of West Broward
Tamarac, Florida, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Heartland Oncology Hematology
Council Bluffs, Iowa, United States
Hematology and Oncology Specialists
Marrero, Louisiana, United States
Metairie Institute of Comprehensive Health
Metairie, Louisiana, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, United States
Washington County Hospital
Hagerstown, Maryland, United States
Josephine Ford Cancer Center
Brownstown, Michigan, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Henry Ford Medical Center Farmington
West Bloomfield, Michigan, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Joan Knechel Cancer Center
Mount Arlington, New Jersey, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Saint Vincent's Comprehensive Cancer Center
New York, New York, United States
Weil Cornell Breast Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Charleston Hematology Oncology Associates PA
Charleston, North Carolina, United States
Cancer Center of North Carolina
Raleigh, North Carolina, United States
Northwest Cancer Specialists Rose Quarter
Portland, Oregon, United States
Northwest Cancer Specialists Hoyt
Portland, Oregon, United States
Northwest Cancer Specialists
Tualatin, Oregon, United States
Lone Star Oncology
Austin, Texas, United States
South Texas Institute of Cancer
Corpus Christi, Texas, United States
Northwest Cancer Center
Corpus Christi, Texas, United States
Texas Oncology-Sammons Cancer Center
Dallas, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Oncology, PA Bedford
Houston, Texas, United States
Texas Oncology, PA
Houston, Texas, United States
North Texas Regional Cancer Center
Plano, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Northern Utah Associates
Ogden, Utah, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Northwest Cancer Specialist Vancouver
Vancouver, Washington, United States
Northwest Cancer Care Specialists, P.C.
Vancouver, Washington, United States
Countries
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Other Identifiers
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E7389-G000-209
Identifier Type: -
Identifier Source: org_study_id
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