Breast Cancer Clinical Trial

A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer

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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT00879086

Recruitment Status:

Completed

Sponsor:

Eisai Inc.

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There are 46 Locations for this study

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Northern AZ Hematology and Oncology Associates
Sedona Arizona, 86336, United States
Healing Hands Oncology and Medical Care
Hawthorne California, 90250, United States
University of Southern California
Los Angeles California, 90033, United States
Comprehensive Cancer Center
Palm Springs California, 92262, United States
Comprehensive Cancer Care Specialist of Boca
Boca Raton Florida, 33428, United States
Robert R. Carroll, MD, PA
Gainesville Florida, 32605, United States
Hematology Oncology Associates
Lake Worth Florida, 33461, United States
Medical Specialists of the Palm Beaches
Lake Worth Florida, 33467, United States
Ocala Oncology Center
Ocala Florida, 34471, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie Florida, 34952, United States
Oncology and Hematology Associates of West Broward
Tamarac Florida, 33321, United States
Hematology Oncology Associates of Illinois
Chicago Illinois, 60611, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Central Indiana Cancer Centers
Indianapolis Indiana, 46219, United States
Heartland Oncology Hematology
Council Bluffs Iowa, 51503, United States
Hematology and Oncology Specialists
Marrero Louisiana, 70072, United States
Metairie Institute of Comprehensive Health
Metairie Louisiana, 70006, United States
Hematology and Oncology Specialists
New Orleans Louisiana, 70115, United States
Maryland Oncology Hematology, PA
Columbia Maryland, 21044, United States
Washington County Hospital
Hagerstown Maryland, 21740, United States
Josephine Ford Cancer Center
Brownstown Michigan, 48183, United States
Henry Ford Medical Center-Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Health Systems
Detroit Michigan, 48202, United States
Henry Ford Medical Center Farmington
West Bloomfield Michigan, 48322, United States
Summit Medical Group
Berkeley Heights New Jersey, 7922, United States
Joan Knechel Cancer Center
Mount Arlington New Jersey, 7856, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States
Saint Vincent's Comprehensive Cancer Center
New York New York, 10011, United States
Weil Cornell Breast Center
New York New York, 10065, United States
Charleston Hematology Oncology Associates PA
Charleston North Carolina, 29403, United States
Cancer Center of North Carolina
Raleigh North Carolina, 27607, United States
Northwest Cancer Specialists Rose Quarter
Portland Oregon, 97227, United States
Northwest Cancer Specialists Hoyt
Portland Oregon, , United States
Northwest Cancer Specialists
Tualatin Oregon, 97062, United States
Lone Star Oncology
Austin Texas, 78759, United States
South Texas Institute of Cancer
Corpus Christi Texas, 78405, United States
Northwest Cancer Center
Corpus Christi Texas, 78410, United States
Texas Oncology-Sammons Cancer Center
Dallas Texas, 75246, 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, 76033, United States
Texas Oncology, PA
Houston Texas, 77024, United States
North Texas Regional Cancer Center
Plano Texas, , United States
Tyler Cancer Center
Tyler Texas, 75702, United States
Northern Utah Associates
Ogden Utah, 84403, United States
Virginia Oncology Associates
Newport News Virginia, 23606, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Northwest Cancer Specialist Vancouver
Vancouver Washington, 98684, United States
Northwest Cancer Care Specialists, P.C.
Vancouver Washington, 98686, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT00879086

Recruitment Status:

Completed

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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