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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



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