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A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

A Phase II, Multicenter, Randomized, Open-Label Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Patients With Advanced Breast Cancer

Inclusion 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:

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of subjects with neuropathy adverse events (AEs) graded according to NCI CTCAE (version 3.0) and coded according to the current version of Medical Dictionary for Regulatory Activities (MedDRA).

Outcome Time Frame:

Neuropathy assessments are performed at the start of Cycles 2-6 and subsequently at every third cycle, end-of-treatment visit, and post-treatment follow-up.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Oncology
  • Breast Neoplasms



Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Virginia Oncology Associates Newport News, Virginia  23606
Montefiore Medical Center Bronx, New York  10467-2490
Ocala Oncology Center Ocala, Florida  34474
Hematology Oncology Associates Atlantis, Florida  33462
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Tyler Cancer Center Tyler, Texas  75702
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Comprehensive Cancer Center Glendale, California  91204
Henry Ford Health Systems Detroit, Michigan  48202
Hematology Oncology Associates of Illinois Skokie, Illinois  60077
North Texas Regional Cancer Center Plano, Texas  75075
Robert R. Carroll, MD, PA Gainesville, Florida  32605
Hematology and Oncology Specialists New Orleans, Louisiana  70115
Texas Oncology, PA Dallas, Texas  75246-2006
Decatur Memorial Hospital Decatur, Illinois  62526
Central Indiana Cancer Centers Indianapolis, Indiana  46227
Texas Cancer Center at Medical City Dallas, Texas  75230
Josephine Ford Cancer Center Detroit, Michigan  48202
Hematology Oncology Associates of Treasure Coast Port St. Lucie, Florida  34952
University of Southern California Los Angeles, California  90033
Washington County Hospital Hagerstown, Maryland  21740
Northwest Cancer Center Houston, Texas  77042
Maryland Oncology Hematology, PA Columbia, Maryland  21044
Summit Medical Group Summit, New Jersey  07901
Northwest Cancer Specialists Portland, Oregon  97225
Henry Ford Medical Center-Fairlane Dearborn, Michigan  48126
South Texas Institute of Cancer Corpus Christi, Texas  78405
Cancer Center of North Carolina Raleigh, North Carolina  27614
Medical Specialists of the Palm Beaches Lake Worth, Florida  33454
Northern AZ Hematology and Oncology Associates Sedona, Arizona  86336
Healing Hands Oncology and Medical Care Hawthorne, California  90250
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Oncology and Hematology Associates of West Broward Tamarac, Florida  33321
Heartland Oncology Hematology Council Bluffs, Iowa  51503
Metairie Institute of Comprehensive Health Metairie, Louisiana  70006
Henry Ford Medical Center Farmington West Bloomfield, Michigan  48322
Joan Knechel Cancer Center Mt. Arlington, New Jersey  07856
Saint Vincent's Comprehensive Cancer Center New York, New York  10011
Weil Cornell Breast Center New York, New York  10065
Charleston Hematology Oncology Associates PA Charleston, North Carolina  29403
Northwest Cancer Specialists Hoyt Portland, Oregon  97213-2996
Northwest Cancer Specialists Rose Quarter Portland, Oregon  97227
Texas Oncology-Sammons Cancer Center Dallas, Texas  75246
Texas Oncology, PA Bedford Houston, Texas  76033
Northwest Cancer Care Specialists, P.C. Vancouver, Washington  98686
Northwest Cancer Specialist Vancouver Vancouver, Washington  98684