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

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Eisai

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Ixabepilone
Drug: Eribulin Mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00879086
E7389-G000-209

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Eribulin mesylate
Active Comparator group
Treatment:
Drug: Eribulin Mesylate
Ixabepilone
Active Comparator group
Treatment:
Drug: Ixabepilone

Trial contacts and locations

50

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Data sourced from clinicaltrials.gov

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