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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00879086

Run by

Eisai Inc.

People needed

104

Starts

2009-03-31

Expected to finish

2014-04-30

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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