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

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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

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.


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
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Jamaica, New York 11432
2443
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Jamaica, NY
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
2438
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Bronx, NY
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3450 Lantana Road Lantana Road
Lake Worth, Florida 33461
2305
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Lake Worth, FL
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
11
mi
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Los Angeles, CA
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433 Southwest 10th Street
Ocala, Florida 34471
2126
mi
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Ocala, FL
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7431 N University Dr # 110
Tamarac, Florida 33321
2306
mi
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Tamarac, FL
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11044 Research Boulevard
Austin, Texas 78759
1209
mi
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Austin, TX
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Berkeley Heights, New Jersey 07922
2410
mi
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Berkeley Heights, NJ
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21020 State Road 7
Boca Raton, Florida 33428
2305
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Boca Raton, FL
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Brownstown, Michigan 48183
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Brownstown, MI
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125 Doughty Street
Charleston, North Carolina 29403
2183
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Charleston, NC
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1730
mi
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Chicago, IL
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Columbia, Maryland 21044
2288
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Columbia, MD
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Corpus Christi, Texas 78374
1295
mi
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Corpus Christi, TX
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14120 Northwest Boulevard
Corpus Christi, Texas 78410
1278
mi
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Corpus Christi, TX
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Council Bluffs, Iowa 51503
1308
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Council Bluffs, IA
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1225
mi
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Dallas, TX
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1223
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Dallas, TX
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Dallas, Texas 75246
1225
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Dallas, TX
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Dearborn, Michigan 48126
1960
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Dearborn, MI
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
1645
mi
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Decatur, IL
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Detroit, Michigan 48202
1965
mi
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Detroit, MI
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6400 West Newberry Road
Gainesville, Florida 32605
2100
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Gainesville, FL
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Hagerstown, Maryland 21740
2240
mi
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Hagerstown, MD
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4253 Redondo Beach Boulevard
Hawthorne, California 90250
23
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Hawthorne, CA
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7515 Main Street
Houston, Texas 76033
1356
mi
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Houston, TX
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Houston, Texas 77024
1349
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Houston, TX
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Indianapolis, Indiana 46227
1794
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Indianapolis, IN
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Lake Worth, Florida 33467
2300
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Lake Worth, FL
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Marrero, Louisiana 70072
1655
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Marrero, LA
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4901 Veterans Memorial Boulevard
Metairie, Louisiana 70006
1648
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Metairie, LA
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657 Willow Grove Street
Mt. Arlington, New Jersey 07840
2390
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Mt. Arlington, NJ
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3525 Prytania Street
New Orleans, Louisiana 70115
1655
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New Orleans, LA
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325 West 15th Street
New York, New York 10011
2432
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New York, NY
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New York, New York 10065
2435
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New York, NY
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Newport News, Virginia 23606
2322
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Newport News, VA
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
2341
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Norfolk, VA
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Ogden, Utah 84403
592
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Ogden, UT
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Palm Springs, California 92262
85
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Palm Springs, CA
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1224
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Plano, TX
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2276
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Port St. Lucie, FL
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265 North Broadway
Portland, Oregon 97227
829
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Portland, OR
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828
mi
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Portland, OR
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Raleigh, North Carolina 27606
2218
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Raleigh, NC
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3700 West State Route 89A
Sedona, Arizona 86336
356
mi
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Sedona, AZ
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Tualatin, Oregon 97062
820
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Tualatin, OR
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Tyler, Texas 75702
1315
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Tyler, TX
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Vancouver, Washington 98684
832
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Vancouver, WA
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2501 Northeast 134th Street
Vancouver, Washington 98686
840
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Vancouver, WA
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6530 Farmington Road
West Bloomfield, Michigan 48322
1951
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West Bloomfield, MI
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